DePuy Mitek, Inc., a leading orthopedics sports medicine company, today announced the launch of the HEALIX™ BR Dual Threaded Anchor System, the first suture anchor for arthroscopic rotator cuff repair made with the company's proprietary BIOCRYL® RAPIDE™ biocomposite material, shown in pre-clinical trials to resorb and promote bone formation within the implant profile2. The announcement was made here at the 27th Annual Fall Meeting of the Arthroscopy Association of North America (AANA).
"BIOCRYL RAPIDE has become an important technology platform in orthopedics sports medicine," said Ian Lawson, Worldwide President, DePuy Mitek. "We will continue to explore its applications with many other products as we stay true to our mission of improving patient quality of life by creating innovative mobility therapies."
The biocomposite material, exclusive to DePuy Mitek products, has more than four years of clinical success in more than 100,000 patients. BIOCRYL RAPIDE is currently used in the MILAGRO Bioreplaceable Interference Screw for anterior cruciate ligament (ACL) repair and the LUPINE™ BR and BIOKNOTLESS BR Suture Anchors for shoulder instability repair.
HEALIX BR is an extension of the successful HEALIX™ PEEK family of anchors. Both anchors are designed to independently engage cortical and cancellous bone, maximizing pull-out strength and potentially minimizing re-tears. HEALIX anchors are available in three sizes (4.5mm, 5.5mm and 6.5mm) to address a wide variety of surgical techniques, and may be pre-loaded with ORTHOCORD, the company's high-strength suture.
"HEALIX BR is a bio-replaceable implant that displays a high level of consistency and strength that is helpful for successful rotator cuff repair," said F. Alan Barber, MD, FACS, Fellowship Director, Plano Orthopedic Sports Medicine and Spine Center.
BIOCRYL RAPIDE has shown in pre-clinical models marked absorption and a proliferation of bone cells after 18 months, with near total absorption in about 24 months2 ("A New Faster-Absorbing Biocomposite Material: Long-Term In-Vivo Tissue Reaction and Absorption," presented at the annual meeting of the AANA in May 2005).
The rotator cuff is a collection of tendons connected to four muscles that cover the upper section of the arm. Active people, including athletes, are susceptible to rotator cuff problems, particularly as they get older. Doctors perform surgery to reattach the rotator cuff to the humerus, or shoulder bone, to relieve pain and increase strength and mobility. Approximately 300,000 rotator cuff surgeries are performed in the U.S. each year.
According to the American Academy of Orthopaedic Surgeons (AAOS), approximately four million people in the U.S. seek medical attention for injuries to the rotator cuff each year3.
About BIOCRYL® RAPIDE™
A proprietary manufacturing process known as Micro Particle Dispersion (MPD) technology enables BIOCRYL RAPIDE to be a homogenous blend of TriCalcium Phosphate (TCP) and Polylactic/polyglycolic Acid (PLGA) particles. BIOCRYL RAPIDE was developed by DePuy Mitek in association with Advanced Technologies and Regenerative Medicine, LLC.
About DePuy Mitek, Inc.
DePuy Mitek, a Johnson & Johnson company, is a leading developer and manufacturer of innovative orthopedic sports medicine products. The company offers minimally invasive, arthroscopic surgical solutions that address the challenges of soft tissue repair in the shoulder, knee and other joints, as well as non-surgical therapies such as ORTHOVISC® for the treatment of osteoarthritis. Through the on-going process of improving upon and creating new, technologically advanced materials, instruments and techniques, DePuy Mitek looks for continued growth in developing the means to advance procedural solutions in the field of sports medicine. For more information, visit depuymitek.
1. Data on file at DePuy Mitek, Inc.
2. Pre-clinical study. Data on file at DePuy Mitek, Inc.
3. aaos/Research/stats/Rotator%20Cuff%20Physician%20Visits.pdf
DePuy Mitek, Inc.
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