March 20, 2024 — PECA Labs, a medical device company reimagining the field of vascular grafts and valves with durable polymeric cardiovascular devices designed to fit, grow, and last, has received an additional CE Mark for its exGraft family of vascular grafts, expanding its on-label use. exGraft vascular grafts are intended for use as vascular prostheses for replacement or bypass of diseased or injured vessels, and with the new clearance, exGraft now includes instructions for post-operative expansion up to 140 percent with the use of oversized balloon catheters.
The exGraft is a synthetic vascular graft built on PECA Labs’ proprietary polymer processing platform that can be permanently expanded. Post-operative expansion is designed to allow for increasing graft diameter, which may enable the graft to match growth in pediatric populations or help to avoid restenosis (narrowing) in adults. Pre-operatively, the controlled dilation may help address unique anatomies. The exGraft’s capability to be balloon-expanded in the cath lab provides cardiac care teams greater flexibility in treating patients.
To help navigate the unique anatomy of each patient, exGraft also includes radiopaque markers, which help ensure accurate identification of the graft in the post-implantation period. The markers are useful during procedures in the cath lab, as well as for following patients using X-rays.
The exGraft received initial CE Mark clearance and 510(k) clearance from the U.S. Food & Drug Administration (FDA) in 2019 for use as a vascular prosthesis and has gained traction within pediatrics, being employed in more than 20 U.S. pediatric hospital centers. It has been implanted in more than 2,000 pediatric patients to date.
“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,” said Doug Bernstein, CEO, PECA Labs. “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.”
As it ramps up commercial operations, PECA opened a new facility for polymeric processing, moving critical manufacturing in-house. With the opening of this site, PECA now has brought a significant portion of the product lifecycle in-house. Located near PECA’s headquarters in the Bloomfield neighborhood of Pittsburgh and in close proximity to University of Pittsburgh Medical Center (UPCMC) Children’s Hospital, the new site will allow PECA greater control of its manufacturing processes and the ability to scale quickly as it grows.
As the company reaches a key inflection point, PECA Labs also named Jeffrey O’Donnell, Sr. as executive chairman. Elevating Mr. O’Donnell to the role of executive chairman will help to drive the company’s strategy as it develops and commercializes cardiovascular implants based on its novel tunable polymeric material platform.
Mr. O’Donnell brings to PECA Labs more than 25 years of board and chief executive experience at emerging medical device companies. He currently serves as managing director for medtech accelerator Runway Healthcare and as managing partner at Lucius Partners. Mr. O’Donnell founded and served as CEO for Trice Medical, and before that Embrella Cardiovascular, which was acquired by Edwards Lifesciences (NASDAQ: EW). He served as president and CEO at both PhotoMedix and Cardiovascular Dynamics, taking the latter public and purchasing Radiance Medical Systems and Endologix.
In 2005, Mr. O’Donnell was named LifeSciences CEO of the Year by Price Waterhouse Coopers. In 2011, Jeff was named the Greater Philadelphia Emerging Entrepreneur of The Year by Ernst & Young. He is also currently the Chairman of the Board of Directors for AerWave Medical and Waypoint Medical. He previously served on the AdvaMed Accel Board of Directors and as an observer on the Membership, Ethics and Technology and Regulatory committees of the AdvaMed Board. Previously, Jeff served as Chairman of the Board for Strata Skin Sciences (NASDAQ: SSKN), as well as a Director on the Board at Cardiac Science and Endologix.
“This is an exciting time for PECA Labs, with its important work about to be realized on a much larger scale,” said Mr. O’Donnell. “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.”
For more information: www.pecalabs.com
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