PECA Labs Receives Expanded CE Mark for its exGraft Vascular Grafts

PECA Labs, a medical device company focusing on vascular grafts and valves with polymeric cardiovascular devices, has received an additional CE Mark for its exGraft family of vascular grafts. 
 
exGrafts are designed to be used as vascular prostheses for the replacement or bypass of diseased, or injured vessels. The new clearance expands its on-label use and includes instructions for post-operative expansion up to 140% with the use of oversized balloon catheters. 
 
PECA Labs initially received its CE Mark and 510k clearance from the FDA in 2019, noting the exGraft’s use as a vascular prosthesis in pediatrics. At the initial clearance, exGraft has been employed in more than 20 US pediatric hospital centers. To date, it has been implanted in over 2,000 pediatric patients. 
 
The exGraft is a synthetic vascular graft that is built on PECA Labs’ proprietary polymer processing platform and can be permanently expanded. Pre-operatively, the dilation can be controlled to address unique anatomies. Post-operative expansion is designed to allow for increasing graft diameter. 
 
The graft can match growth in pediatric populations to help avoid restenosis (narrowing) in adults. exGraft has balloon-expanding capabilities in the cath lab to provide greater flexibility in treating patients. 
 
It also includes radiopaque markets to help ensure accurate identification post-implantation. These markers can be useful during cath lab procedures and in following patient x-rays.  
 
“This CE Mark clearance, which results in an expanded label within the exGraft family of vascular grafts, is extremely significant. Not only does it validate the potential of our controllably-expandable polymer conduit, but it also means the world to patients seeking options for a number of cardiovascular diseases and conditions,” PECA Labs CEO, Doug Bernstein commented. “Pre-operatively, exGraft expansion is designed to allow for customizable geometries to address complex anatomies, and improve outcomes of some procedures. Post-operatively, expansion via a minimally-invasive procedure is designed to provide growth potential and reduce the risk of restenosis, which is key to reducing the need for revision surgeries.”
 
PECA has also opened a new facility for polymetric processing and moved critical manufacturing in-house. The company brings a significant portion of the product lifecycle in-house by opening this new site. The new facility is located near PECA’s headquarters in Bloomfield, PA and it is closely located near the University of Pittsburgh Medical Center (UPCMC) Children’s Hospital. 
 
Additionally, the company promoted Jeffrey O’Donnell, Sr. as executive chairman. He will help drive company strategy as it develops and commercializes cardiovascular implants. 
 
O’Donnell brings over 25 years of experience having served as CEO and on the board of directors for multiple emerging medical device companies. Currently, he also serves as managing director for Runway Healthcare and as a managing partner at Lucius Partners, as well as chairman of the board of directors for AerWave Medical and Waypoint Medical. 
 
“This is an exciting time for PECA Labs, with its important work about to be realized on a much larger scale. The company shows great promise, with innovative technologies that I believe will be a game-changer in the cardiovascular space, providing a great benefit to patients, surgeons and interventionalists alike,” O’Donnell said.