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*OPINION: Advice for Edwards Lifesciences – Mitral Valve Replacement is The Next Big Thing

Edwards Lifesciences’ partnership with a broad group of hospitals, as well as surgeons and interventional cardiologists has resulted in a fruitful relationship.

One of those is with Cedars Sinai Medical Center in Los Angeles. At OCTANe’s recent annual medtech forum, the lifesciences behemoth discussed its internal incubation process and asked for advice from Cedars’ cardiologist Raj Makkar.

Edwards – OC’s largest public company, with HQ in Irvine — creates medical equipment, specializing in artificial heart valves and hemodynamic monitoring, measuring the blood pressure inside the veins, heart, and arteries.

Bernard Zovighian, who leads a new transcatheter mitral and triscuspid therapies unit for Edwards, discussed with Makkar the potential of the several new technologies Edwards is incubating internally.

The two spoke about addressing unmet patient needs through “disruptive innovation.”

Makkar gave Zovighian the advice of waiting to see the results of clinical trials before deciding which devices to pursue, emphasizing that “edge-to-edge” mitral valve repair has already proven itself as viable.

This edge-to-edge technique was introduced in 1991 and has progressively been used to restore mitral functioning, especially in the case of “mitral regurgitation,” when the mitral valve doesn’t close tightly, allowing blood to flow backward into the heart.

Mitral valve replacement is “the next big thing,” Makkar said.

Medtronic, among others, is already engaged in clinical trials in this realm, he pointed out.

There’s also been an encouraging shift in the FDA to slightly ease the approval process in this area, Makkar said. So while there’s still the tendency for giant corporations like Edwards to be risk-averse, the downside is the potential of missing out on new and critical opportunities.

More About Edwards’ Portfolio Incubation Paradigm

The current options for patients with mitral or tricuspid disease are either surgery or no dedicated therapy. These patients oftentimes have complex diseases and they may only be addressed if they are having surgery for another issue in their heart (more true of tricuspid valve disease vs. mitral valve. The tricuspid valve would not have an isolated surgery to address issues; but the mitral valve would).

Because these patients are complex and varied as far as how the disease affects their heart and health, it’s important for physicians to have a number of treatment options available, i.e. options for both repair and replacement of valves, as well as different types of methods of repair.

This is why Edwards is taking a portfolio approach to addressing mitral regurgitation and tricuspid regurgitation patients — so that physicians have several options available to provide a transcatheter treatment for their disease.

Nimbleness in Past

Makkar reminded Zovighian of Edwards’ nimbleness in innovating quickly in the past and testing multiple versions of aortic valves in a matter of months. Edwards was able to iterate this product forward, develop a market for it and do clinical trials – all on parallel tracks – so it could bring the product to market quickly and safely.

“The fear of the unknown in being first to market did not stop you,” he told Zovighian.

Edwards got FDA approval of its first transcatheter device in 2011, eliminating the need for open-chest heart surgery, according to news reports. This aortic heart valve is made of bovine tissue, within a collapsible stainless-steel stent, and deployed via catheter through the blood vessels.

Makkar holds several titles at Cedars Sinai, including the Stephen R. Corday, M.D. Chair in Interventional Cardiology  and the director of interventional cardiology at its Cardiac Catherization Lab. 



About The Author

Deirdre Newman is a long-time journalist, who's covered OC startups for a few years.

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