FDA advisory panel discusses application of collagen scaffold for meniscal injuries

The FDA Orthopedic and Rehabilitation Devices Panel recently collected and reviewed information on a premarket notification 510(k) application for a collagen scaffold to be used for the reinforcement and repair of chronic soft tissue meniscal injuries with weakness.

The information will be used to aid the FDA in making a final decision regarding clearance of ReGen Biologic’s Collagen Scaffold.

“While panel meetings are most often convened to review premarket approval applications (PMAs), the Center for Devices and Radiological Health has asked for panel review of other premarket notice applications,” an FDA spokesperson told Orthopedics Today. “Regulations give us the authority to seek expert opinion from panel members for whatever product or topic we feel could benefit from the discussion.”

She added, “The FDA has been working with ReGen for the past several years. In the interest of timely product review, and given both the availability of qualified members in our pool of Advisory Committee panel experts and the willingness of ReGen to participate, we are holding this meeting to gain the committee’s recommendations and help the agency make a final determination on the company’s application.”

According to the 510(k) submission, the mesh device would be indicated for cases with meniscal weakness and in patients who have an intact meniscal rim and anterior and posterior horns for mesh attachment. The surgically prepared site must also extend into the red/white zone of the meniscus to provide for vascularity. Although not included in the original premarket notification submission, the company also proposed an acute indication. If cleared by the FDA, the collagen scaffold would be the first surgical mesh device approved for this application.

After hearing histologic, animal and clinical evidence presented by the FDA and device sponsor, the panel answered five FDA questions regarding the mechanical integrity of the scaffold, its ability to foster tissue growth, clinical issues related to its use and its indication for acute injuries.

Panel members said they generally believed that the the collagen scaffold shows evidence of fostering soft tissue ingrowth and clinically offers promise. However, they expressed concerns regarding patient selection and application.

“Clinically, this product alone offers great promise,” John D. Kelly IV, MD, said. “Alone, it is safe, but the applications are concerning. What I do not want to see happen is a journeyman-arthroscopist say, ‘I can help you,’ [and] then do a very morbidity-associated, elaborate repair.” Due to those concerns, the panel advised that surgical training be considered as part of the approval.

The panel members also noted that the mesh device was as safe and effective as a predicate device. Likewise, they said the device was appropriate for acute soft tissue meniscal injuries and noted the importance of patient selection and surgical indications for such cases.

“Acute and chronic [cases are] indicated, but with strong caution, given the surgical community and their predilection for new devices and putting it in every environment,” Hollis G. Potter, MD, said. “I think that we have to be very careful about selection.”

For more information:
Hollis G. Potter, MD, has a consulting agreement with a competing firm.

Reference:
www.fda.gov