A tale of two devices – succeeding and failing in the clinical marketplace

“The indications for surgery are well defined, the surgery is straightforward, many people need it, and the outcomes are usually quite good,” said Dr. Chetcuti.

Still, the operation carries a perioperative mortality rate of up to 10% and usually a need for lifelong anticoagulant therapy. Despite all of that, aortic valve replacement has been widely adopted and continues to evolve. The latest iteration uses a built-in filter to catch any liberated emboli.

Teamwork has also greatly enhanced the technical success and evolution of heart valve surgery, Dr. Chetcuti said. “The new paradigm, and the reason this has truly become a technical success, is the combined heart team. It’s a really robust team effort that crosses borders – it includes the cardiologist, the interventionalist, the primary care physician, and the anesthesiologist. And it has to include the hospital administrator, especially when you’re implementing a new technology with no set plan for reimbursement. You need a support team to grab this thing and make it work.”

msullivan@frontlinemedcom.com@alz_gal

^1.This is where the AGA Center for GI Innovation and Technology comes in. The center helps companies develop their early studies in a way that captures the data needed by other regulatory groups, such as CMS and private payers, who need different data than the FDA to cover and pay for technology. Learn more about the center by visiting www.gastro.org.