Peca Labs’ exGraft Family of Vascular Grafts Receives Expanded CE Mark

March 19, 2024—Peca Labs announced it has received an additional CE Mark for its exGraft family of vascular grafts. The exGraft is a synthetic vascular graft built on Peca Labs’ polymer processing platform that can be permanently expanded.

According to the company, exGraft vascular grafts are intended for use as vascular prostheses for replacement or bypass of diseased or injured vessels. With the new clearance, exGraft now includes instructions for postoperative expansion up to 140% with the use of oversized balloon catheters.

The company stated that postoperative 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 in adults. Preoperatively, the controlled dilation may help address unique anatomies. The exGraft’s capability to be balloon-expanded in the catheterization lab provides cardiac care teams greater flexibility in treating patients, noted Peca Labs.

The exGraft also includes radiopaque markers to help navigate the unique anatomy of each patient and help ensure accurate identification of the graft in the postimplantation period.

Peca Labs advised that the exGraft received initial European CE Mark clearance and FDA 510(k) clearance in 2019 for use as a vascular prosthesis and has gained traction within pediatrics, being employed in more than 20 pediatric hospital centers in the United States.

The company also announced that its board of directors member Jeffrey O’Donnell, Sr. has been named executive chairman. In this role, O’Donnell will drive the company’s strategy as it develops and commercializes cardiovascular implants based on its tunable polymeric material platform.

The press release stated that 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 the managing director for medtech accelerator Runway Healthcare and as managing partner at Lucius Partners. O’Donnell founded and served as CEO for Trice Medical, and before that Embrella Cardiovascular, which was acquired by Edwards Lifesciences. He served as President and CEO at both PhotoMedix and Cardiovascular Dynamics, taking the latter public and purchasing Radiance Medical Systems and Endologix. 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. He served as the chairman of the board for Strata Skin Sciences, as well as a director on the board at Cardiac Science and Endologix.

Additionally, the company has opened a new facility for polymeric processing, moving critical manufacturing in-house as it ramps up commercial operations. The facility is located near Peca’s headquarters in the Bloomfield neighborhood of Pittsburgh, Pennsylvania, and close to the University of Pittsburgh Medical Center Children’s Hospital.