Nusurface Meniscus Implant Fda Approval

" The meniscus is a tissue pad between the thigh and shin bones, and once damaged, the meniscus in middle aged patients has a very limited ability to heal itself. In an effort to gain regulatory approval, the NUsurface Meniscus Implant is currently in an FDA-approved multi-center, randomized, control trial comparing it to the current standard-of-care for patients with persistent knee pain following meniscus surgery. The procedure begins with routine arthroscopic preparation of the meniscus, explains Active Implants (Memphis, TN), which developed and markets the NUsurface Meniscus Implant. When people injure their meniscus, the fibrous shock absorber in their knee, the torn part is often removed. , the NUsurface® Meniscus Implant, from Active Implants LLC, is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. 24 articles with Active Implants Corporation. Meniscus Implant Investigational NUsurface®Meniscus Implant is the first “artificial meniscus” designed to replace one that is damaged or deteriorated. Typically, the injured meniscus is trimmed and things are tied down around. TOCA (The Orthopedic Clinic Association) Performs First Meniscus Replacements in Arizona with NUsurface® Meniscus Implant: Phoenix Suns Physician Treats Local Resident with Persistent Knee Pain in SUN Clinical Trial – Dr. The NUsurface meniscus implant is the first “artificial meniscus” to be marketed in Europe and, if cleared by FDA, would be the first artificial meniscus USFDA grants approval to Medtronic’s Valiant NavionTM LSA Branch Thoracic Stent Graft System. The ReGen Collagen Scaffold (also known as Menaflex™ collagen meniscus implant) was the only collagen meniscus implant with FDA clearance at this time. In fact, as opposed to the FDA regulatory review where there is an open exchange of questions and responses, you are not allowed to converse with the CMS panels. FDA Breakthrough Device Designation Given to Active Implants for NUsurface Meniscus Implant Latest Breaking News From Printed Electronics Now NAUM 19: Future of Materials with Graphene Nanotubes Starts in Japan. Active Implants LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain… Active Implants LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active. To receive FDA clearance for its NUsurface Meniscus Implant, Active Implants enrolled its final patient in the two clinical trials to test the implant's efficiency. Vidya has 7 jobs listed on their profile. Best advice, start early and hire a good advisor. , to receive a NUsurface meniscus implant through an FDA-approved study with Arlington Orthopedic. and the data gathered will be filed for FDA approval in the U. The NUsurface Meniscus Implant, a replacement for the knee joint’s cartilage pad between the thigh and shin bones, has gone into a second clinical trial to assess its safety and effectiveness in. Food and Drug Administration (FDA) approval in August 2015. Food & Drug Administration, the NUsurface Implant would be the first "artificial meniscus. 24 articles with Active Implants Corporation. This all could change thanks to the NUsurface Meniscus Implant, which is currently undergoing an FDA trial in the United States. Food & Drug Administration (FDA) to sell the device in the U. If approved by the U. FDA Breakthrough Device Designation Given. In September 2009, the FDA issued a preliminary repo rt on the review of the ReGen. Outcome Measures The outcomes of this treatment (ie, pain, functional status) are subjective, patient-reported outcomes that are prone to placebo effects. Active Implants "Active Implants has commercialized two unique orthopedic implants in Europe with a visible pathway to bring them into the U. Yankel Gabet liked this. Menaflex™ collagen meniscus implant) was the only c ollagen meniscus implant with FDA clearance at this time. The SUN study (Safety Using NUsurface®) will enroll approximately 120 patients as part of regulatory process to gain approval from FDA to sell the device in the U. Currently three of these implants, two partial and one total replacement, are clinically available and several others are in the stage of preclinical testing. Results of the VENUS and SUN trial, which has also completed enrollment, will support a de novo clearance from US FDA, which would make it the first artificial meniscus approved in the US. Suganya Kandasamy, ing. This product offers an excellent value in use and is FDA approved for food contact. Here's what you need to know: 1. , professor of Orthopaedic Surgery … to receive either the. Food and Drug Administration within the next two years. Best advice, start early and hire a good advisor. The NUsurface Implant is made from medical grade plastic and is designed not to require fixation to bone or soft tissue. The report provides comprehensive information on the pipeline products with comparative analysis of the products at various stages of development. The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011. About the Clinical Trial. Two of Abbott's paediatric devices—Masters HP 15mm rotatable mechanical heart valve and the Amplatzer Piccolo Occluder—have received European approval (CE mark). Amid controversy about the 510(k) clearance for the ReGen Collagen Scaffold, the FDA initiated a review of the clearance process for this device. Enrollment in two FDA clinical trials was completed in the US in July, 2018. The SUN (Safety Using NUsurface) clinical trial is the second one initiated by Active Implants LLC to evaluate its investigational NUsurface meniscus implant. Price had his ACL replaced in his left knee, and his meniscus was removed because of a tear, about 10 years ago after playing basketball. basic science and regulatory research plans, as well as clinical research of the final product. Nikki Hinton liked this. 8 At 24 months, a clinical success rate of 80 percent for the endpoints of pain, function and safety occurred for the Cartiva. Food & Drug Administration, the NUsurface Implant would be the first "artificial meniscus. swelling tummy in kids. It also includes listings for associations and consultants, with detailed contact information for all companies. Currently, the only FDA approved synthetic meniscus replacement product is NUSurface. The anisotropic approach was also followed by an Israeli company that recently started the first clinical trials to evaluate in vivo performance of their polyethylene reinforced polycarbonate urethane (PCU) meniscus implant (NUsurface®, Fig. About the Clinical Trial. Synthetic meniscus replacement: A review HA and SAPL. The NUsurface Meniscus Implant, a replacement for the knee joint’s cartilage pad between the thigh and shin bones, has gone into a…. It also serves to produce lubricants. Olympic Team Treats Carlsbad Resident with Persistent Knee Pain in SUN Clinical Trial. The study is a prospective, randomized, multicenter study to demonstrate superiority of the device compared to the current standard. In September 2009, the FDA issued a preliminary repo rt on the review of the ReGen. Requests directly related to medical policy content or clinical criteria requests may be sent to the Medical Policy Operations Specialist via email, phone or mail. FDA approval of BurstDR Stimulation, a spinal cord stimulation option for patients suffering from chronic pain U. Orthopedics devices maker Active Implants touted the close of the 1st $8. The study is a prospective, randomized, multicenter study to demonstrate superiority of the device compared to the current standard-of-care for patients with persistent knee. Current controlled trials do not report improvements in outcomes for most pain and functional status measures. Clinical studies are being performed to evaluate efficacy of the collagen meniscus implant (CMI®) and a polyurethane polymeric implant (Actifit®). After highlighting relevant anatomy and emerging magnetic resonance (MR) imaging techniques, this article reviews the current indications and techniques used for meniscus surgery, evaluates the use of MR imaging protocols with and without arthrography, and focuses on MR imaging interpretation of the. To learn about our use of cookies and how you can manage your cookie settings, please see our Cookie Policy. NUsurface Meniscus Implant — developed and marketed by Memphis, Tenn. To learn more about the study, visit or call (844) 856-4100 or visit www. 24 articles with Active Implants Corporation. Approved IDE Studies The following IDE studies have met CMS’ standards for coverage. MEMPHIS, Tenn. , to receive a NUsurface meniscus implant through an FDA-approved study with Arlington Orthopedic. The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011. Food and Drug Administration (FDA) through the 510(k) process. If approved, says the company, the NUsurface Implant would be the first "artificial meniscus. The NUsurface® System is an “artificial meniscus” implant designed to replace the damaged one. The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and in Israel since 2011. Amid controversy about this 510(k) clearance decision, FDA reviewed its decision. FDA Breakthrough Device Designation Given to Active Implants for NUsurface Meniscus Implant If approved by the FDA, NUsurface would be the first artificial meniscus in the United States. Vetalice | Sep 2019 Breakthrough Device Designation is designed to ensure that patients and providers have timely access to vital devices. “If we get to a decade, we’ll be thrilled,” says Henry Klyce, chief executive of Active Implants. 23, that its artificial meniscus has received a key FDA designation. Active Implants said today it launched a new site at in its Venus trial looking to investigate its NUsurface investigational meniscus implant for treating persistent knee pain caused by. The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011. The NUsurface meniscus implant is implanted through a mini-open procedure in conjunction with routine arthroscopy, without the need to replace the kneecap. FDA Approves Abbott's 'Low Dose' Neurostimulation Device for Chronic Pain Abbott's Proclaim XR spinal cord stimulation system is recharge-free, uses a low energy therapy and low dosing protocol, and runs on a battery that lasts up to 10 years. Amid controversy about this 510(k) clearance decision, FDA reviewed its decision. Meniscal transplant surgery. After highlighting relevant anatomy and emerging magnetic resonance (MR) imaging techniques, this article reviews the current indications and techniques used for meniscus surgery, evaluates the use of MR imaging protocols with and without arthrography, and focuses on MR imaging interpretation of the. Active Implants LLC 09. 5 NUSurface Meniscus Implant 46. To learn about our use of cookies and how you can manage your cookie settings, please see our Cookie Policy. Orthopedics devices maker Active Implants touted the close of the 1st $8. Two hundred and thirty (230) patients will participate. Typically, the injured meniscus is trimmed and things are tied down around. " In an effort to gain regulatory approval, the NUsurface Meniscus Implant is currently in an FDA-approved multi-center, randomized, control trial comparing it to the current standard-of-care for patients with. NUsurface is made of a composite polymer and is designed to help patients who have osteoarthritis-related pain and disability, where the condition stems from a previous surgery or meniscus-related problems, the company explains. He took part in a clinical trial for a meniscus implant product seeking approval from the U. Active Implants’ Nusurface Receives Breakthrough Designation From FDA. 3, 2018 – PeekMed® reached510(k) clearance for its orthopedic planning system, from the U. 1,6-Hexanediol (HDO) is used to manufacture industrial coatings including lower volatile organic compound formulations, polyurethanes, adhesives, and. The SUN study (Safety Using NUsurface®) will enroll approximately 120 patients as part of regulatory process to gain approval from FDA to sell the device in the U. The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011. It has been available in Europe since 2008. Learn more about the FDA's breakthrough designation for our NUsurface Meniscus Implant in this in-depth article from Sunday's The Daily Memphian. Food & Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to conduct a pivotal clinical trial of the NUsurface® Meniscus Implant for early. Learn more about the FDA's breakthrough designation for our Active Implants’ president and CEO hopes to shave time off the FDA approval process for the. Active Implants’ NUsurface meniscus implant was granted a Breakthrough Device designation from the U. One total meniscus replacement that is in early phase clinical testing is NUsurface® (Active Implants); it is composed of a polyethylene reinforced polycarbonate urethane. ” The SUN study plans to enroll 120 patients as part of the regulatory process to gain approval from the FDA to sell the device in the U. The collagen and polyurethane meniscus implants do not have FDA approval. If approved by the Food & Drug Administration, the NUsurface Implant would be the first “artificial meniscus. Food & Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to conduct a pivotal clinical trial of the NUsurface® Meniscus Implant for early Knee OsteoArthritis. 8 in London, after approval from the relevant antitrust authorities. NEW YORK (CBSNewYork) — If your knees feel stiff, ache and creak when you walk, then you are like millions of other Americans. The study is a prospective, randomized, multicenter study to demonstrate superiority of the device compared to the current standard. NUsurface is being tested around the country for FDA-approval testing. More news related to sports medicine: American Sports Medicine Institute newest advocate is the 'Doc': 4 things to know. This implant is an artificial device made from polycarbonate-urethane (PCU) and reinforced with Ultra High Molecular Weight Polyethylene fibers. The SUN study (Safety Using NUsurface®) will enroll approximately 120 patients as part of regulatory process to gain approval from FDA to sell the device in the U. process to gain approval from FDA to sell the device in the U. Menaflex CMI and Actifit ® scaffolds have received the Conformité Européenne (CE) mark in Europe, and NUsurface ® Meniscus Implant has been used in Europe under CE Mark since 2008 and since 2011 in Israel. The new application gives Mako the ability to implant Stryker’s Triathlon knee, which won U. Two of Abbott’s paediatric devices—Masters HP 15mm rotatable mechanical heart valve and the Amplatzer Piccolo Occluder—have received European approval (CE mark). 7 million tranche in a $26 million financing round in support of its NUsurface meniscus implant for repairing damage in the. , to receive a NUsurface meniscus implant through an FDA-approved study with Arlington Orthopedic. THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT - 73 OuroBoros received approval in Europe for its MIS OSS device, which is designed to circumferentially expand in the interbody disc space and contain graft materials to support fusion. FDA Approval 'Finally' Recognizes Vertebral Body Tethering as a Mainstream Scoliosis Treatment Zimmer Biomet's first-of-its-kind spinal tether device sets the stage for helping thousands of kids with scoliosis, according to a top scoliosis. We are excited to announce that our NUsurface® Meniscus Implant has been granted a Breakthrough Device Designation from the U. As a result of its unique. Jack Kucheran, DC, Calgary, AB T1Y6X3 Canada, 2011 Condition: Torn Medial Meniscus/left knee pain, medial knee pain, joint restriction and loss of range of motion (ROM), left leg muscle atrophy, unable to climb stairs up or down without pain, experienced pain every step and had a limp. Active Implants LLC today announced the first implantation in the United States of the NUsurface® Meniscus Implant, designed to treat patients with persistent knee pain due to an injured or. " KAEDING SAID. The study is a prospective, randomized, multicenter study to demonstrate superiority of the device compared to the current standard-of-care for patients with persistent knee. Seems easy but can actually be more difficult then regulatory approval as the decision is not made in an open discussion. Active Implants’ NUsurface meniscus implant was granted a Breakthrough Device designation from the U. Studies with the Category A are approved for coverage of routine services. If the FDA approves the NUsurface, however, the implant could help over a million Americans a year who have had meniscus surgery (the same amount as the number of hip and knee replacements a year. Successful Treatment of Knee Injury. The SUN and VENUS U. The FDA granted Breakthrough Device Designation to Active Implants' Nusurface meniscus implant, the company announced Sept. In October 2010, FDA rescinded the approval, stating that MenaFlex. Results of the VENUS and SUN trial, which has also completed enrollment, will support a de novo clearance from US FDA, which would make it the first artificial meniscus approved in the US. See the complete profile on LinkedIn and discover Andy’s connections and jobs at similar companies. The artificial meniscus device is already available in Europe and, if cleared by FDA, would also be the first artificial meniscus in the United States. , Jan 26, 2015 (BUSINESS WIRE) -- Active Implants LLC today announced the first implantation in the United States of the NUsurface® Meniscus Implant, designed to treat patients with. Active Implants is sponsoring two clinical trials to support regulatory approval from the U. Best advice, start early and hire a good advisor. Is Inflammation Affecting Your Health? Controlling Inflammation With Diet. In Europe, the CMI is approved for use in a clinical setting for medial meniscus injury. An artificial Polycarbonate-urethane implant has been developed for replacement of the medial meniscus [91, 92, 93]. "Active Implants has commercialized two unique orthopedic implants in Europe with a visible pathway to bring them into the U. only collagen meniscus implant (CMI) with FDA clearance at that time. The Future of Knee Repair led the nation's first FDA-approved, multi-center, randomized control trial for the NUsurface Meniscus Implant, manufactured by Active. The procedure begins with routine arthroscopic preparation of the meniscus explains Active Implants (Memphis TN) which developed and markets the NUsurface Meniscus Implant. All patients who meet study requirements and agree to enter the trial are offered the NUsurface Meniscus Implant as treatment. Active Implants LLC 09. FRISCO, Texas–(BUSINESS WIRE)–After four long years, the Volvo brand is coming back to the Frisco area. Cohan received the NUsurface Meniscus Implant on May 21, , through a small incision in her right knee and completed a six-week rehabilitation. About the NUsurface® Meniscus Implant The NUsurface® Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. Food and Drug Administration within the next two years. This gamma type violet 19 is a high quality, yellow shade with excellent performance in coatings, powder coatings, inks and plastics. Active Implants was founded in 2004 by Amiram Steinberg who previously founded Implant Ltd. The company has reportedly decided that FDA approval procedures are too arduous, and it prefers to defer them until it has sales and cash flow in Europe. Active Implants, LLC, a developer of orthopedic implant solutions for joint preservation, today announced that the NUsurface® Meniscus Implant has been granted a Breakthrough Device Designation. You will be allowed to go home the same day or. ” The SUN study plans to enroll 120 patients as part of the regulatory process to gain approval from the FDA to sell the device in the U. Nusurface), Menaflex® (by ReGen Biologics, USA) is the FDA approved collagen (derived from purified bovine Achilles tendons) meniscus implant (CMI ®). A torn meniscus is an all too common injury that can be quite painful on its own and leads to earlier onset of arthritis. NUsurface Meniscus Implant — developed and marketed by Memphis, Tenn. Active Implants is sponsoring two clinical trials to support regulatory approval from the U. FDA has granted Active Implants' NUsurface meniscus implant a breakthrough device designation. Although the NuSurface meniscus implant is an investigational device, it's manufacturers have been granted an exemption approved by the FDA for the purpose of these trials. " Kaeding said. Studies with the Category B are approved for coverage of the Category B device and related services, and routine services. Amid controversy about this 510(k) clearance decision, FDA reviewed its decision. NUsurface is made from medical grade plastic and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissue. -powered X-ray system. " The meniscus is a tissue pad between the thigh and shin bones, and once damaged, the meniscus in middle aged patients has a very limited ability to heal itself. When it gets torn, every step becomes painful because there's nothing to cushion the impact of the knee bones. The letter is 5 pages long. The device imitates the meniscus, a pad of cartilage between the thigh and shin bones that functions as a shock absorber. Haselmeier’s Axis-D auto-injector pen is approved for use by the European Medical Agency and the FDA, among other regulatory bodies. Amid controversy about this 510(k) clearance decision, FDA reviewed its decision. Suganya Kandasamy, ing. The novel, composite polymer implant is for osteoarthritis patients who have pain and disability but are too old or young for a total knee replacement. "If this meniscal implant works as well as we think it will, it fills a gap in our treatment for those with meniscus injuries. The FDA determined that this device was substantially equivalent to existing absorbable surgical mesh devices. "In particular, it [is] seeking FDA approval of its NUsurface Meniscus Implant which is the first 'artificial meniscus' and intended to fill the gap between minimally invasive meniscus repair and total knee replacement. Financial News - Breaking news, mergers and acquisitions, personnel, financial news, product releases from flexible and printed electronics manufacturers and suppliers. The FDA Breakthrough Devices Program was implemented to expedite the development and review process for medical devices that are novel or offer new technology for patients with life. Progressively, the implant will form a customized fit to the patient's knee contour. , resident Rob Price at Brigham and Women’s Hospital before Thanksgiving. This implant is an artificial device made from polycarbonate-urethane (PCU) and reinforced with Ultra High Molecular Weight Polyethylene fibers. The NUsurface® Meniscus Implant, from Active Implants LLC, is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. The Latest Knee Implant Surgery Devices The meniscus of the knee is a sort of pad that keeps the large, heavy bones of the joint from abrading each other with every step. Food and Drug Administration. The NUsurface meniscus implant developed by Active Implants (Memphis, TN) provides a new treatment Eric E. Although Active Implants has EU CE Mark approval for the product, it decided not to begin sales until it completes a large clinical trial to demonstrate the product's safety, performance. Amid controversy about this 510(k) clearance decision, FDA reviewed it decision. Two hundred and thirty (230) patients will participate. The SUN study will enroll approximately 120 patients as part of regulatory process to gain approval from FDA to sell the device in the U. " The meniscus is a tissue pad between the thigh and shin bones, and once damaged, the meniscus in middle aged patients has a very limited ability to heal itself. The SUN study plans to enroll 120 patients as part of the regulatory process to gain approval from the FDA to sell the device in the U. The FDA Breakthrough Devices Program was implemented to expedite the development and review process for medical devices that are novel or offer new technology for patients with life. Who is a candidate for an artificial meniscus implant? For the majority of patients with meniscus damage, arthroscopic surgery to clean out the torn tissue leads to satisfactory outcomes. The implant is currently being tested in two FDA-approved clinical trials, which completed enrollment in June 2018. Food and Drug Administration. The study is a prospective, randomized, multicenter study to demonstrate superiority of the device compared to the current standard-of-care for patients with persistent knee pain following meniscectomy surgery. The SUN study (Safety Using NUsurface®) will enroll approximately 120 patients as part of regulatory process to gain approval from FDA to sell the device in the U. Amid controversy about the 510(k) clearance for the ReGen Collagen Scaffold, the FDA initiated a review of the clearance process for this device. The SUN trial is designed to test the safety and effectiveness of the NUsurface Meniscus Implant in restoring knee function similar to a healthy meniscus. Active Implants’ NUsurface meniscus implant was granted a Breakthrough Device designation from the U. market for knee implants a matured market and projected to witness steady growth over the forthcoming years. Federal Government. The “NUsurface” implant, manufactured by Active Implants, a Tennessee-based company specializing in orthopaedic implants, is currently being tested in an FDA-approved multicenter, randomized. Unlike premarket notification, PMA approval is to be based on a determination by FDA that the PMA contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses. , to receive a NUsurface meniscus implant through an FDA-approved study with Arlington Orthopedic. Browse by category to find a supplier who can help enhance your products. FDA Breakthrough Device Designation Given to Active Implants for NUsurface Meniscus Implant Latest Breaking News From Printed Electronics Now NAUM 19: Future of Materials with Graphene Nanotubes Starts in Japan. " Kaeding said. The artificial meniscus device is already available in Europe and, if cleared by FDA, would also be the first artificial meniscus in the United States. Results of the VENUS and SUN trial, which has also completed enrollment, will support a de novo clearance from US FDA, which would make it the first artificial meniscus approved in the US. About the NUsurface® Meniscus Implant In the U. The SUN (Safety Using NUsurface) clinical trial is the second one initiated by Active Implants LLC to evaluate its investigational NUsurface meniscus implant. The device imitates the meniscus, a pad of cartilage between the thigh and shin bones that functions as a shock absorber. Active Implants LLC today announced the first implantation in the United States of the NUsurface® Meniscus Implant, designed to treat patients with persistent knee pain due to an injured or. FDA Breakthrough Device Designation Given. Associate Orrick, Herrington & Sutcliffe LLP January 2007 – June 2009 2 years 6 months. Currently three of these implants, two partial and one total replacement, are clinically available and several others are in the stage of preclinical testing. Approved IDE Studies The following IDE studies have met CMS' standards for coverage. Table 18: NUsurface Meniscus Implant - Treatment of the Medial Meniscus with the Nusurface Meniscus Implant 28 Table 19: NUsurface Meniscus Implant - Verifying the Effectiveness of the NUsurface System: A Multi-center, Prospective, Randomized, Interventional, Superiority Clinical Study (The VENUS Clinical Study) 29. Active Implants, LLC has been granted Investigational Device Exemption (IDE) approval by the FDA to conduct a pivotal clinical trial for its NUsurface Meniscus Implant. There are seven locations participating in the randomized, controlled trial for approval. In an effort to gain regulatory approval, the NUsurface Meniscus Implant is currently in an FDA-approved multi-center, randomized, control trial comparing it to the current standard-of-care for patients with persistent knee pain following meniscus surgery. The […] Axonics touts one-year data for r-SNM device, inks. In an effort to gain regulatory approval, the NUsurface Meniscus Implant is currently in an FDA-approved multi-center, randomized, control trial comparing it to the current standard-of-care for. Active Implants said today it launched a 2nd clinical trial to evaluate its NUsurface meniscus implant designed to be meniscus replacement for patients looking to avoid or delay total knee. The NUsurface® System is an “artificial meniscus” implant designed to replace the damaged one. It has been used in Europe and Israel since 2008, and is now undergoing a clinical trial in the U. Device makes debut at Cosmoprof. The procedure begins with routine arthroscopic preparation of the meniscus explains Active Implants (Memphis TN) which developed and markets the NUsurface Meniscus Implant. Price became the first man in New England to be given the implant, which is still awaiting approval from the U. Amid controversy about this 510(k) clearance decision, FDA reviewed its decision. Active Implants, LLC, a developer of orthopedic implant solutions for joint preservation, today announced that the NUsurface® Meniscus Implant has been granted a Breakthrough Device Designation. The SUN study (Safety Using NUsurface®) will enroll approximately 120 patients as part of regulatory process to gain approval from FDA to sell the device in the U. Active Implants raises $26M to continue EU clinical trial of meniscus implant, NUsurface Active Implants LLC Closes $26. Meniscus surgery is common, and surgical indications and techniques continue to evolve. I need to put together a letter that will convince the Pscy. Best advice, start early and hire a good advisor. About the Clinical Trial. Studies with the Category A are approved for coverage of routine services only. The SUN trial is designed to test the safety and effectiveness of the NUsurface Meniscus Implant in restoring knee function similar to a healthy meniscus. 2183 Azo Yellow 183 2183 is a high heat stable, diarylide-free, yellow for powder coatings. Prior to coming to The Stone Clinic, Matt's knees were considered bone on bone and he had a failed OATS procedure, meniscectomy and microfracture. Financial News - Breaking news, mergers and acquisitions, personnel, financial news, product releases from flexible and printed electronics manufacturers and suppliers. Sometimes it is sutured. Cohan received the NUsurface Meniscus Implant on May 21, , through a small incision in her right knee and completed a six-week rehabilitation program A March 1 voluntary recall of blood pressure medications by Torrent Pharmaceuticals is being further expanded by the company over detection of a nitrosamine impurity, according to a Food and Drug. It has been used in Europe and Israel since 2008, and is now undergoing a clinical trial in the U. Food and Drug Administration within the next two years. Active Implants raises $26M to continue EU clinical trial of meniscus implant, NUsurface Active Implants LLC Closes $26. The NUsurface® Meniscus Implant is the first "artificial meniscus" to be marketed in Europe and, if cleared by the FDA, would be the first artificial meniscus in the U. Gay liked this Learn more about the FDA's breakthrough designation for our. Active Implants LLC 09. Active Implants Receives FDA Breakthrough Device Designation for NUsurface® Meniscus Implant OrthoSpin Receives FDA Regulatory Clearance New Hybrid Remote Patient Monitoring System Feasible and Motivating Following Total Knee Arthroplasty GE's health unit wins first FDA clearance for A. Amid controversy about the 510(k) clearance for the ReGen Collagen Scaffold, the FDA initiated a review of the clearance process for this device. " The meniscus is a tissue pad between the thigh and shin bones, and once damaged, the meniscus in middle aged patients has a very limited ability to heal itself. The WiSE CRT System improves heart’s pumping ability by synchronizing left and right ventricles to distribute blood to lungs and body more effectively. , the NUsurface® Meniscus Implant (pronounced “new surface”) from Active Implants LLC is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. 7 million in. Active Implants, LLC has been granted Investigational Device Exemption (IDE) approval by the FDA to conduct a pivotal clinical trial for its NUsurface Meniscus Implant. Amid controversy about this 510(k) clearance decision, the FDA reviewed its decision. This implant is an artificial device made from polycarbonate-urethane (PCU) and reinforced with Ultra High Molecular Weight Polyethylene fibers. The molds were used to produce all the scaffolds for further characterization. This all could change thanks to the NUsurface Meniscus Implant, which is currently undergoing an FDA trial in the United States. This gamma type violet 19 is a high quality, yellow shade with excellent performance in coatings, powder coatings, inks and plastics. patients who continue to suffer from knee pain after meniscus surgery, but are too young for total knee replacement may soon have a new treatment option. -(BUSINESS WIRE)-Active Implants, the technology leader in cushion-bearing orthopedics for treatment of osteoarthritis, today announced it has received Investigational Device Exemption (IDE) approval to conduct a pivotal clinical trial of the NUsurface® Meniscus Implant in patients with knee osteoarthritis. Garrett Jr. A new cartilage-like hydrogel material could make the job of repairing knees much easier, say scientists, as it's 3D printable and can be made as an exact fit for each individual knee. FDA determined that this device was substantially. Studies with the Category B are approved for coverage of the Category B device and related services, and routine services. For more than 30 years, the magazine has tracked the growth of the nonwovens industry through years of changes, technology, evolution and market development. FDA grants Breakthrough Device Designation for meniscus implant. About the NUsurface® Meniscus Implant The NUsurface® Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. Results from the trial are part of a regulatory process to help Active Implants to gain FDA approval to sell the device in the United States. Current controlled trials do not report improvements in outcomes for most pain and functional status measures. About the Clinical Trial The SUN study (Safety Using NUsurface®) will enroll approximately 120 patients as part of regulatory process to gain approval from FDA to sell the device in the U. 100th Patient Enrolled In Clinical Trials For Active Implants' Nusurface Meniscus Implant. Studies with the Category A are approved for coverage of routine services only. Food & Drug Administration, the NUsurface Implant would be the first "artificial meniscus. The NUsurface® Meniscus Implant, from Active Implants LLC, is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. Active Implants LLC 09. The designation allows an expedited review of the NUsurface meniscus implant from Active Implants. Active Implants Receives FDA Breakthrough Device Designation for NUsurface® Meniscus Implant OrthoSpin Receives FDA Regulatory Clearance New Hybrid Remote Patient Monitoring System Feasible and Motivating Following Total Knee Arthroplasty GE’s health unit wins first FDA clearance for A. 8 in London, after approval from the relevant antitrust authorities. Suganya Kandasamy, ing. The NUsurface® System is an “artificial meniscus” implant designed to replace the damaged one. Progressively, the implant will form a customized fit to the patient's knee contour. Garrett Jr. Even if NUsurface wins Food and Drug Administration approval, it isn’t clear how long the implant will last. " "We are now one step closer to filling the gap in treatment options between minimally invasive meniscus repair and total knee replacement, which is a large unmet need in the orthopedic market," said Ted Davis, president and CEO of Active Implants. When people injure their meniscus, the fibrous shock absorber in their knee, the torn part is often removed. Active Implants said yesterday that it won breakthrough device designation from the FDA for its NUsurface meniscus implant, the first of its kind to be marketed in Europe and, if cleared by the. Enrollment in two FDA clinical trials was completed in the US in July, 2018. The NUsurface ® Meniscus Implant is made from polycarbonateurethane (PCU)– a medical grade plastic. Progressively, the implant will form a customized fit to the patient's knee contour. NUsurface is made from medical grade plastic and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissue. FDA Breakthrough Device Designation Given. The NUsurface Meniscus Implant, a replacement for the knee joint’s cartilage pad between the thigh and shin bones, has gone into a…. In October 2010, FDA rescinded the approval, stating that MenaFlexTM is intended for different purposes and is technologically dissimilar from the predicate devices identified in the approval. See the complete profile on LinkedIn and discover Andy’s connections and jobs at similar companies. Grossmont Orthopaedic Medical Group Performs First Meniscus Replacement in San Diego with NUsurface® Meniscus Implant: Local Orthopedic Surgeon and Team Doctor for U. Gay liked this Learn more about the FDA's breakthrough designation for our. Home » 7 medtech stories we missed this week: June 9, The purpose of the clinical trial is to test the NUsurface Meniscus Implant that is designed to treat persistent knee pain from injured. The NUsurface meniscus implant developed by Active Implants (Memphis, TN) provides a new treatment Eric E. Jon Foerster, 44, of Denton became the first person in Texas, and one of the first in the U. Trimethylolpropane (TMP) is a high-quality intermediate that is used primarily for the production of alkyd resins, which are used in paints and coatings. The SUN study (Safety Using NUsurface®) will enroll approximately 120 patients as part of regulatory process to gain approval from FDA to sell the device in the U. Active Implants Receives FDA Breakthrough Device Designation for NUsurface® Meniscus Implant OrthoSpin Receives FDA Regulatory Clearance New Hybrid Remote Patient Monitoring System Feasible and Motivating Following Total Knee Arthroplasty GE's health unit wins first FDA clearance for A. A PMA is an application submitted to FDA to request approval to market. Meniscal transplant surgery. Manufacturers, prior to placing their devices in the market, are required to determine the classification of a device, based on the risk factors associated with each device, and then. This minimally invasive procedure only uses a small incision for the implant. In an effort to gain regulatory approval, the NUsurface Meniscus Implant is currently in an FDA-approved multi-center, randomized, control trial comparing it to the current standard-of-care for patients with persistent knee pain following meniscus surgery. When your meniscus becomes inflamed or degraded, the resulting pain can be intense. meniscus implant (CMI) with FDA clearance at that time. Food & Drug Administration, the NUsurface Implant would be the first "artificial meniscus. The NUsurface Meniscus Implant is being used in a clinical trial at Ohio State’s Wexner Medical Center and is being compared to the current standard-of-careRead More Central Ohio , columbus ohio , implant , knee , knee meniscus , meniscus implant , meniscus repair , torn meniscus Medical News Comments are Off. It also includes listings for associations and consultants, with detailed contact information for all companies. Who is a candidate for an artificial meniscus implant? For the majority of patients with meniscus damage, arthroscopic surgery to clean out the torn tissue leads to satisfactory outcomes. Active Implants is sponsoring two clinical trials to support regulatory approval from the U. "If this meniscal implant works as well as we think it will, it fills a gap in our treatment for those with meniscus injuries. Active Implants, LLC, a developer of orthopedic implant solutions for joint preservation, today announced that the NUsurface® Meniscus Implant has been granted a Breakthrough Device Designation. Unlike premarket notification, PMA approval is to be based on a determination by FDA that the PMA contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses. Our International Buyers' Guide contains information on suppliers of ingredients, machinery/equipment and packaging materials, as well as contract services. Food and Drug Administration. If approved by the U.