FDA Approves TAVR System for High-Risk Aortic Stenosis

The US Food and Drug Administration (FDA) has approved a minimally invasive transcatheter aortic valve replacement (TAVR) system for the treatment of patients with severe aortic stenosis who are at risk for significant surgery.

The approval of Boston Scientific Corporation’s LOTUS Edge Aortic Valve System provides a new option for cardiologists treating patients at greater risk for surgical valve replacement via open heart surgery.

The TAVR system is the only aortic valve approved by the FDA that provides a repositioning option and gives physicians the opportunity to completely recapture the valve once it has been deployed. Its braided valve frame and adaptive seal conforms to the patient’s native aortic valve, according to Boston Scientific, meaning risks for paravalvular regurgitation or leaking (PVL) are minimized.

Aortic stenosis currently affects about 7% of the world’s population over the age of 65, and carries a 50% survival rate at 2 years post-onset, and 20% at 5 years, if patients do not receive an aortic valve replacement.

In a Medtronic-supported study presented at the 2019 American College of Cardiology (ACC) 2019 Annual Meeting this year, an adaptive TAVR device was shown to improve outcomes in patients with severe aortic stenosis and a low surgery risk.

In an interview with MD Magazine®, Michael J. Reardon, MD, professor of Cardiothoracic Surgery and Allison Chair of Cardiovascular Research at Houston Methodist Hospital, recalled that it was once theorized that TAVR could serve as an alternative option to surgery and low-risk care. That has quickly changed—TAVR is likely the preferred therapy among the studied patient population now.

“And when I talk to patients in my office now, when they come in with aortic stenosis and they're a candidate for a biologic surgical valve because of age and other criteria—if I don't talk to them about TAVR, I have not given them really true informed consent, and we're not doing true shared decision-making,” Reardon said.

Just weeks from launching the TAVR system in European markets, Boston Scientific now intends to begin a controlled launch in the US in the following weeks. Ian Meredith, AM, executive vice president and global chief medical officer of Boston Scientific, expressed thrill in the system reaching both markets.

“This system provides physicians a high level of control over the delivery and deployment of the device and offers surgical-like PVL results to help ensure the best patient outcomes,” he said in a statement.