DRUG/DEVICE PRODUCTS... - Medical Device Daily

90DRUG/DEVICE PRODUCTS...DIALING UP THE COMBINATIONPegasus gets FDA okay forOrthAdapt biologic scaffoldBy KAREN YOUNGMedical Device Daily Staff WriterPegasus Biologics (Irvine, California) secured FDA 510(k) clearance in 2005 for the OrthAdaptBioimplant, the privately held company’s first product, which it called “an intelligent, adaptable biologicscaffold.”The company secured clearance to use its bioimplants to reinforce compromised soft tissues in sportsmedicine, orthopedic and spine applications.Pegasus founder and president France Dixon Helfer told Medical Device Daily that she is thrilled thatthe company has been cleared to offer its first product.“Under the FDA, [OrthAdapt] was classified as a surgical mesh. It is a natural piece of equine pericardium,and we decellularize it and crosslink it to stabilize tissue, and then we terminally sterilize it withoutchanging any of the properties of the tissue,” she said.It would be reinforcing any of the soft-tissue defects for which it is used, Helfer said.The company said that the Pegasus UltiFIX technology renders the product fully biocompatible, whilethe UtiliSTER technology terminally sterilizes the bioimplant “without the use of damaging chemicals orradiation.”“It’s very, very adaptable, and that’s why it’s called OrthAdapt,” Helfer said.For example, she said, in sports medicine the company can repair injuries to the rotator, the Achillestendon, biceps or “any types of tendons that require a reconstructive material to reinforce” them.With spine defects, Helfer said there are “quite a few applications for us, including some of the ligamentsof the spinal area that need a strong material that is completely biocompatible and sterile -that’s an area we’re just getting into.”The company has approval for three different types of crosslinking, which it refers to as FX, PX and MX.“OrthAdapt FX is a bioimplant that will last a long, long time and slowly get integrated and slowly getremodeled and replaced by the patient’s tissue,” she said.OrthAdapt MX will “get replaced much more rapidly,” Helfer said, while OrthAdapt PX is in the middlerange of the time it takes for integration into a person’s tissues.“Depending on the indication and the application, the different options would be available,” she said.Larry Lemak, a sports medicine surgeon in Birmingham, Alabama, said, “As a practicing physician,I am excited about the release of the OrthAdapt Bioimplant. It will provide use with a significant newoption for many soft tissue surgeries including repairs of the shoulder, knee, foot and ankle. The scientificstudies performed on the OrthAdapt Bioimplant, demonstrating excellent biocompatibility andtissue regenerating properties, are promising.”Heading the sales and marketing effort for OrthAdapt will be Al Weinstein, executive vice president ofsales and marketing, whom Helfer said has “a long and very, very successful track record” in introducingnew products.“His last big success was Opus Medical,” she said. “Prior to that it was ArthroCare. He has a greatnetwork of surgeons [and] physicians who like following [him] and seeing what the next big producthe’s going to be out with” is.Helfer said Pegasus will be doing a “very careful launch.” Initially, the company will be working with themembers of the surgical advisory board that Weinstein has assembled.“Although the FDA gave us the clearance to market our products, we are going to be defining and refiningthe actual surgical techniques for each of the indications that we’re pursuing, and we’re going to dothat with our surgical advisors,” she told MDD.That way, she said, “we will follow our success,” and by perfecting the techniques with its advisors, theTo subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 688-2421; outside the U.S. and Canada, call (404) 262-5476.Copyright © 2007 AHC Media LLC. Reproduction is strictly prohibited.