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Healthy Innovation Record

Stanton Rowe’s nearly 40-year career in medical devices has been one of intersection and innovation. He has played a crucial role in the development of what’s considered one of the major advances in replacement heart valves.

“I exist in that space between the business world, the medical world and the technological world,” said Rowe, Irvine-based Edwards Lifesciences Corp.’s corporate vice president, advanced technology, and chief scientific officer.

He’s one of six Orange County executives and entrepreneurs who received an inaugural Innovator of the Year Award from the Business Journal on Sept. 24 at Hotel Irvine (see related stories, pages 1, 4, 6, 8, 9 and 10).

Rowe “currently leads Edwards Lifesciences’ efforts to discover and develop medical technologies in structural heart disease and critical care that will impact patient care—and potentially change the practice of medicine—well into the future,” according to the award nomination form Edwards executives submitted.

The efforts include what’s now known as the Edwards Sapien family of less-invasive heart valves, which are implanted in patients via a catheter rather than through open-heart surgery. Sapien and its predecessors came to Edwards in early 2004 when the company paid $125 million to buy Percutaneous Valve Technologies Inc., which was based in Fort Lee, N.J.

Rowe, Stanley Rabinovich and Drs. Martin Leon and Alain Cribier, inventor of the Cribier-Edwards investigational heart valve that evolved into Sapien, co-founded Percutaneous Valve in 1999 backed by Medica Venture Partners.

“It started with this really wonderful idea. After years of work, Dr. Cribier … had this idea that we could expand a heart valve in a patient’s heart without opening up their chest,” Rowe said in 2012 during a TEDx Orange Coast talk.

Imagine

“Imagine replacing a heart valve without looking at it—only through X-rays—sparing these old patients open-heart surgery [and] cardiac arrest,” Rowe said of Cribier’s invention.

Edwards’ acquisition of Percutaneous Valve “brought together two teams who were dedicated to helping patients with heart-valve disease,” Rowe said last week.

The Edwards and Percutaneous Valve teams were able to come together because Edwards had its own development program for transcatheter aortic valves, and the combination enabled a quicker move, according to Rowe.

“We had real challenges in early clinicals … we had to learn, adapt, pause and go back for another try,” Rowe said.

“To innovate takes perseverance and commitment, and Edwards brought this spirit to this development when things were tough.”

Rowe said, “Edwards does not just talk about innovation—we invest in it.” Edwards expects to spend about $360 million this year on research and development.

Sapien has been used to treat more than 100,000 patients around the world. The first-generation valve was introduced in Europe in 2007 and approved by the Food and Drug Administration in late 2011.

The device accounted for $541 million in sales for Edwards in the first half of this year. Edwards says the majority of the company’s growth—its total revenues were up 10% in that six-month period to $1.2 billion—was driven by “significant transcatheter aortic heart valve sales.”

Rowe’s group at Edwards also is working on a transcatheter mitral valve replacement study of people who have mitral valve disease but can’t have a traditional surgical valve replacement. The company also recently signed a $400 million deal to buy Irvine-based CardiAQ Valve Technologies Inc., another developer of less-invasive mitral heart valves.

“Stan’s leadership is critical in ensuring that we continue to innovate and transform patient care,” Rowe’s nomination form said.

He “has the unique combination of rare vision, deep clinical relationships and insight to patients suffering from cardiovascular disease,” the company said.

Rowe also has a deep intellectual property position—he has been awarded 20 patents and has 39 pending.

Rowe holds a bachelor’s degree in biological sciences from the University of Alabama in Huntsville.

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