Peca Labs 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 postoperative expansion up to 140% with the use of oversized balloon catheters.
A press release details that exGraft is a synthetic vascular graft built on Peca Labs’ proprietary polymer processing platform that can be permanently expanded. Postoperative expansion is designed to allow for increasing graft diameter, which may enable the graft to match growth in paediatric 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 cath lab provides cardiac care teams greater flexibility in treating patients.
To help navigate the unique anatomy of each patient, the press release continues, 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 US Food & Drug Administration (FDA) in 2019 for use as a vascular prosthesis and has gained traction within paediatrics, being employed in more than 20 US paediatric hospital centres. It has been implanted in more than 2,000 paediatric 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. “Preoperatively, exGraft expansion is designed to allow for customisable geometries to address complex anatomies, and improve outcomes of some procedures. Postoperatively, 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.”
