Why is this important?
Reason #1 – The “Breakthrough Device Designation” is new for Orthopedics. Active Implants is either the 1st or 2nd ortho company to ever to receive this designation. (see chart)
Distribution of granted breakthrough device designation requests across common clinical specialties and medical device areas.
Reason #2 – Historically, the “Breakthrough Device Designation” yields a higher clearance rate (see chart)
Summary data for breakthrough device designation requests.
Read below the FDA’s 2018 report to Congress about the Breakthrough Device program.
Read below the FDA’s Breakthrough Device guidance document. The advantages for devices designated as a Breakthrough Device are on pages 3 to 6.
First ‘Artificial Meniscus’ wins FDA Breakthrough Device Designation (MDDI by Amanda Pedersen)
The designation allows an expedited review of the NUsurface meniscus implant from Active Implants.
U.S. 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. FDA has granted Active Implants’ NUsurface meniscus implant a breakthrough device designation.
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.
Earlier this year Active Implants gained some attention from Needham & Co.’s Mike Matson, who included the company on a list of interesting private medtech companies.
“Active Implants has commercialized two unique orthopedic implants in Europe with a visible pathway to bring them into the U.S.,” Matson noted in his June 2019 report. “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.”
Ted Davis, president and CEO of Memphis, TN-based Active Implants, said the company expects to have the data required for an FDA submission next year.
The NUsurface meniscus implant is designed for patients with persistent knee pain following medial meniscus surgery. It is made from medical-grade polymer and, as a result of its unique materials, composite structure, and design, does not require fixation to bone or soft tissues. The NUsurface Implant is intended to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. The device is currently marketed in Belgium, Germany, Italy, and Israel.
“The breakthrough device designation is a significant step in our mission to fulfill a substantial unmet need in the U.S. orthopedic market,” Davis said.
FDA’s 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-threatening or irreversibly debilitating conditions. The agency has been rapidly accepting devices into this pathway this year. Recent breakthrough device designations include a drug-eluting balloon for below-the-knee peripheral artery disease as well as a drug-coated balloon catheter for the same indication from Concept Medical, an interatrial shunt for heart failure from V-Wave, B. Braun’s drug-coated PTCA balloon catheter for the treatment of coronary in-stent restenosis, a coronary intravascular lithotripsy catheter from Shockwave Medical, a clot ingestion system from Perfuze, and two cancer diagnostic tests.
Press Release
Active Implants Receives FDA Breakthrough Device Designation for NUsurface® Meniscus Implant (press release)
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 from the U.S. Food and Drug Administration. 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.S.
“This will be significant for this patient population, who often don’t have good treatment options”
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-threatening or irreversibly debilitating conditions. This program is designed to ensure patients and healthcare providers have more timely access to vital devices.
“The Breakthrough Device Designation is a significant step in our mission to fulfill a substantial unmet need in the U.S. orthopedic market,” said Ted Davis, president and CEO of Active Implants. “We believe we will have the data required for our FDA submission next year, after completing enrollment in our clinical trials in 2018. We look forward to working closely with the FDA to expedite the review process for the NUsurface® Implant to provide a new treatment option to the hundreds of thousands of patients who continue to experience persistent knee pain following meniscus surgery, but are too young for total knee replacement.”
“This will be significant for this patient population, who often don’t have good treatment options,” said Elliott Hershman, MD, practicing orthopedic surgeon and medical director for the NUsurface clinical trials. “I’m pleased to hear the FDA will prioritize its review of this important new device and possibly make this therapy available for use by other knee surgeons for their American patients.”
The meniscus is a tissue pad between the thigh and shin bones. Current treatment for a damaged or torn meniscus includes pain management, physical therapy, injections, repair techniques or meniscectomy. It has been estimated that from 700,000 to over 1 million partial meniscectomies are performed annually in the U.S. in an attempt to alleviate pain; however, studies have shown that many people who get a meniscectomy continue to experience pain that impacts their quality of life and can eventually lead to knee replacement surgery.1
About the NUsurface® Meniscus Implant
The NUsurface® Meniscus Implant is an investigational treatment for patients in the U.S. with persistent knee pain following medial meniscus surgery. It is made from medical grade polymer and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissues. The NUsurface® Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. The NUsurface® Implant is currently marketed in Belgium, Germany, Italy and Israel.
About Active Implants LLC
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 lifestyle. Active Implants is privately held with headquarters in Memphis, Tennessee. European offices are in Haarlem, The Netherlands, with R&D facilities in Netanya, Israel. For more information, visit www.activeimplants.com.
CAUTION Investigational device. Limited by United States law to investigational use.
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1 Brophy RH, Gray BL, Nunley RM, Barrack RL, Clohisy JC. J Bone Joint Surg Am. 2014;96(10):801-805. http://dx.doi.org/10.2106/JBJS.M.00105
Contacts
Joni Ramirez
Merryman Communications
joni@merrymancommunications.com
323.532.0746