Changing Minds While Innovating Hearts

(Image credit: Edwards Lifesciences)

When Stan Rowe took his search for funding a minimally-invasive alternative to heart valve replacement to VCs on Sand Hill Road back in 2000, he was told they’d check with experts — in this case, cardiothoracic surgeons — and get back to him.

Rowe, who is corporate vice president and chief scientific officer at Edwards Lifesciences, described their reaction:

“They wanted to tell me all the reasons why it wouldn’t work.”

How that “thing” went from radical idea to an FDA-approved product delivering better than an 85% survival rate after 1-year for high risk and formerly inoperable patients in one test alone, is a story about a project that needed to change minds as it, literally, innovated hearts.

Edwards has been in the structural heart business for over a half-century, and surgeons had been its primary customers, as heart repair or replacement surgery revolutionized the survival rate for patients with heart valve disease (an estimated 5 million Americans are diagnosed annually). Many more patients received arterial stents to treat their heart disease — one estimate puts it over a million annually in the US — which were inserted by interventional cardiologists.

Usually, the latter handed patients off to the former when stent treatment was deemed inappropriate, as there was little overlap of what each of them could treat. Further, many patients were deemed high risk or inoperable for any help whatsoever.

It was clear that Edwards’ innovation, which used a stent-like procedure to insert a new valve into the aortic valve’s place, would only be prescribed to those patients in greatest need if both areas of expertise participated in the diagnosis.

“In our studies [begun in 2007], we demanded that each site form a heart team of echo cardiographer, cardiothoracic surgeon, intervention cardiologist, and nurse who runs the valve clinic,” Rowe explained.

“It meant every patient was presented options by a team, and it worked so well that we made it a requirement when we rolled out the product commercially.”

Rowe had been CEO of Percutaneous Valve Technologies, which was developing the novel procedure, when Edwards acquired the company in 2004 to add to its own work coming out of Irvine, CA. Not only were the skills complementary but, as he remembers it, “the Irvine team knew who they players were inside the company, and how to get things done.”

The project faced numerous technical challenges, and some of them were of their own making, like working on next generation versions of products — ways to improve its profile, durability, accessories, and even patient selection methodology — from day one.

“I lived through the first stent launch at Cordis/J&J,” Rowe said. “After selling $650 million in the first year, two years later we went from 94 to 30% market share because we didn’t have a pipeline of improved products behind it.”

Edwards’ latest product iteration, SAPIEN 3, features design enhancements to the valve and smaller delivery catheter sizing, some of which were on the drawing board when the team brought out the first version. Taken together, the SAPIEN family of valves has been used in the treatment of more than 150,000 patients globally.

Now, Rowe leads an advanced technology group, which houses experts from materials science, prototyping, manufacturing, and regulatory affairs. They’re focused on 7 year+ development windows that are approximately two-thirds technical, and one-third trials/communications before launch.

“Our job is to create new therapies to help underserved patients,” Rowe added.