PECA Labs has added Joseph E Bavaria (Jefferson Health and Sidney Kimmel Medical College, Philadelphia, USA) to its board of directors. Bavaria, a cardiac surgeon, will provide leadership to PECA as it continues to develop and commercialise cardiovascular implants based on its novel tunable polymeric material platform.
He brings more than 30 years of experience in cardiac and thoracic surgery, research and leadership to PECA’s board. He is currently chair of Cardiac Surgery at Jefferson Health and executive director of the Jefferson Heart and Vascular Institute in Philadelphia.
Previously he spent more than three decades at Penn Medicine where he served in a number of leadership roles, including vice chief, Division of Cardiovascular Surgery, director of the thoracic aortic surgery programme, co-director of the transcatheter valve programme, and founder of the Penn Aorta centre.
Bavaria has completed extensive research and served in international leadership positions including president of the Society of Thoracic Surgeons (STS), president of the Thoracic Surgery Foundation (TSF), board member of the Heart Valve Society, and executive committee member of the European Association of Cardio-Thoracic Surgery (EACTS).
“Dr Bavaria’s extensive leadership in cardiovascular surgery, particularly in innovating valve repair and replacement, will be immeasurable as we continue to develop and commercialize our MASA Valve and our STEALTH valve technologies,” said Doug Bernstein, CEO of PECA Labs. “Few have the combination of hands-on, research and educational experience as Dr Bavaria, making him an enormous asset as we move closer to our goal to provide devices that reduce or eliminate the need for replacement surgeries, thereby reducing the risk of morbidity and mortality in at-risk patients.”
PECA Labs’ MASA valve is a durable polymeric valved conduit for pulmonary valve reconstruction. Designed for paediatrics, the MASA valve is designed to help patients avoid repeat surgeries and reduce morbidity and mortality.
The novel polymeric valve previously received Humanitarian Use Device (HUD) and investigational device exemption (IDE) from the US Food and Drug Administration (FDA).
Enrolment continues at four clinical sites in the USA as part of its MASA valve early feasibility clinical study (MVEFS).
PECA Labs developed the MASA Valve to be made entirely of polymeric materials that help avoid body’s immune response and valve calcification that are inherent to biologic valved conduits and the leading cause of valve failure.
The MASA valve is constructed of PECA’s proprietary conduit and leaflet membrane, allowing for the production of a wide array of sizes to ensure a match with each patient’s unique anatomy. The MASA valve could help reduce the need for replacement surgeries and interventions, thereby reducing the risk of morbidity and mortality. If approved, the MASA valve would be the only non-biologic valve replacement option for this important procedure, and aims to be the first fully polymeric valve on the market.
PECA’s first FDA-cleared implant is the exGraft, a polymeric graft indicated for use as a vascular prosthesis. exGraft recently received a new CE mark as well to allow for the use of over-sized balloon dilation.
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 (narrowing) in adults.
“PECA Labs is working to solve some important challenges in cardiovascular implants, including the use of next-generation polymeric materials, which could make significant improvements to patient outcomes,” said Bavaria. “I look forward to working with the company and rest of the board of directors in an effort to create a meaningful impact with its technologies.”
