Newspaper article Pittsburgh Post-Gazette (Pittsburgh, PA)

Medical Innovation Pittsburgh Maker of Heart Device Makes Mark in Europe

Newspaper article Pittsburgh Post-Gazette (Pittsburgh, PA)

Medical Innovation Pittsburgh Maker of Heart Device Makes Mark in Europe

Article excerpt

Five years ago, a trio of recent Carnegie Mellon University graduates hatched an idea for a new pediatric heart valve, spending nights and weekends developing the device in a small storefront they leased in Etna next door to a tattoo shop.

Five years later, they're in a much nicer office space in Lawrenceville, across from Children's Hospital of Pittsburgh of UPMC. More importantly, they've just been handed the keys to hospital surgical suites throughout Europe.

Earlier this spring, the three PECAlabs founders - CEO Doug Bernstein, 26, COO Jamie Quinterno, 27, and Chief Scientific Officer Arush Kalra, 30 - learned they've received European CE mark certification, akin to FDA approval in the U.S., for an innovative conduit called exGraft for use in children's heart surgery. The conduit allows surgeons to detect any twisting or kinking, said Ergin Kocyildirim, a pediatric cardiothoracic surgeon at Children's Hospital.

"As there are marked visible lines [on the exGraft], this is both helpful to estimate measurements at the operating table and to follow up by a simple X-ray, instead of a CT scan," significantly reducing the amount of radiation to the patient, he said.

It's not their centerpiece product Masa valve, named in honor of former Children's surgeon Masahiro Yoshida. But it's a start.

After meeting with pediatric cardiac surgeons in seven European countries last month, they are now talking to distributors there to market exGraft as they work toward hoped-for FDA approval and a piece of the $10 billion heart valve market.

As they prepare for the next big step, they've added two more full-time employees: Susan Speicher as director of quality and regulatory affairs, and Denver Falk as director of pre-clinical development.

"There's a point where you have to go from a startup to a real company," said Mr. Quinterno, and clearly they believe PECAlabs - the name is inspired by their specialization in pediatric cardiovascular devices - has hit that threshold.

The Masa valve and exGraft use a material derived from Gore-Tex known as ePTFE, or expanded polytetrafluoroethylene, which they have modified so "it is half as thick but three times as strong," said Mr. …

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