– Orteq® Sports Medicine Announces 5-Year Multicenter Clinical Data Publication for Actifit® Meniscal Implant in the American Journal of Sports Medicine (AJSM), Receives Innovative Device Designation from FDA
LONDON, May 26, 2020 / PRNewswire / – Orteq Sports Medicine Ltd. (www.orteq.com [https://c212.net/c/link/?t=0&l=es&o=2811956-1&h=1459533028&u…]), a developer of joint preservation solutions for orthopedic patients, announces 5-year, multi-center, peer-reviewed clinical data published in the AJSM analyzing the Actifit meniscal implant showing more than 87% survival rates with increased knee function and pain reduction. The implant has received an innovative device designation from the United States Food and Drug Administration.
The Orteq Actifit Meniscal Implant has been implanted in more than 4,000 patients with irreparable damage to the meniscal cartilage in 30 countries around the world and has now been published in 25 peer-reviewed clinical journals. Actifit is a biodegradable polymer designed to preserve the knee joint and promote the growth of new tissue in damaged areas of an irreparable meniscus, the crescent-shaped cartilage pad that acts as a buffer between the thigh (femur) and the bones shinbone (tibia).
Current treatment options for damaged, ruptured, or irreparable middle (internal segment) or lateral (external segment) meniscus include pain management, physical therapy, injections, repair, and surgical removal of a portion of a torn meniscus ( partial meniscectomy) or surgery in which a meniscus from a cadaver (allograft meniscus) is placed on the knee.
Approximately 1.5 million arthroscopic partial meniscectomies are performed worldwide to reduce a patient’s knee pain, with half the cases in the United States. However, numerous clinical studies have shown that many patients who receive a partial meniscectomy continue to experience pain that may eventually lead to knee replacement surgery.
Professor Em Rene Verdonk (Department of Orthopedic Surgery and Traumatology, Erasme ULB Hospital, Brussels, Belgium) said, “The recent AJSM publication on mid-term multicenter European follow-up of 155 patients shows that Actifit significantly improved the articular function of the knee and reduced pain in patients with an irreparable segmental meniscus defect for more than five years after implantation.Treatment survival rates of 87.9% for internal segment (medial) implants and 86.9% of the external (lateral) segment implants in this study compared favorably with MAT (meniscal allograft transplant) for total meniscectomy. In addition, Actifit offers significant health savings and cost savings over currently available transplant products. ”
The FDA introduced the Innovative Devices Program for new medical devices in 2017 to accelerate the process of developing and reviewing new technologies for patients with life-threatening or irreversibly debilitating conditions. This program is designed to ensure that American patients and healthcare providers have more timely access to vital devices.
“The Innovative Device Designation program enables companies to obtain a ‘fast’ review that could lead to American patients gaining faster access to healthcare technology. We look forward to submitting our extensive European clinical data to the FDA for review. analysis this year and work closely with the agency, “said Simon Coles, CEO and Director of Orteq Sports Medicine Ltd.
“This will be significant for a young patient population without many satisfactory treatment options,” said Peter Kurzweil, MD, a sports medicine physician in Long Beach, CA and a member of the Orteq Surgical Advisory Council. “I am delighted that the FDA has granted this expedited review of Actifit technology. I am looking forward to offering Actifit to my patients in the future.”
Coles also said that achieving these significant milestones has accelerated Orteq’s expansion activities. “We have recruited an experienced global management team, obtained a new CE mark from the European Union, established a new EU office in Utrecht, the Netherlands, and obtained regulatory approval in Korea. Our goal in the next two years is to accelerate Actifit regulatory approvals from 30 to 50 countries, streamline our Actifit US presentation using the new FDA Innovative Designation status, and rapidly develop the patented Actifit polymer platform to other musculoskeletal joints. “
For more information about Actifit, contact us at www.orteq.com [https://c212.net/c/link/?t=0&l=es&o=2811956-1&h=1459533028&u…]
About ActifitActifit is a synthetic implant with a highly interconnected porous structure, made from a patented biocompatible and biodegradable polymer. When implanted into the arthroscopically medial or lateral meniscus of a patient Actifit (r) allows the growth of native tissue and acts as a new “shock absorber” to relieve pain and restore the patient’s functional mobility. It is currently designed only for irreparable partial meniscus loss or damage.
The main European clinical investigators for Actifit are Philippe Beaufils, MD, PhD, Orthopedic Department, Center Hospitalier de Versailles, Le Chesnay, France and Professor Emeritus Rene Verdonk, Department of Orthopedic Surgery and Traumatology, Erasme ULB Hospital, Brussels, Belgium. Actifit is available at the following world renowned clinics in Europe and the Gulf States.
Prof Peter Verdonk, Orthoca Orthopedic Center, Antwerp, Belgium https://orthoca.be/dokters-orthopedie/dr-peter-verdonk [https://c212.net/c/link/?t=0&l=es&o=2811956-1&h=900214019&u=…]
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