Dive Brief:

• FDA has granted breakthrough device designation to a transcatheter tricuspid valve replacement system from startup Cardiovalve.

• In a statement Thursday, Cardiovalve revealed the designation alongside news that the agency cleared it to run an early feasibility study in tricuspid regurgitation.

• The decisions position Cardiovalve to gather clinical data in tricuspid regurgitation patients, building on its study of mitral regurgitation patients, furthering efforts to enter markets targeted by Abbott, Edwards Lifesciences and Medtronic.

Dive Insight:

Cardiovalve spun out of Valtech Cardio at the time of the latter company’s acquisition by Edwards in 2017. With Edwards having two investigational mitral valve replacement devices on its books at the time of the Valtech takeover, it opted to exclude Cardiovalve from the acquisition but retain an option to buy the spin-out. Edwards’ decision made Cardioband, a rival to Abbott’s MitraClip, the focus of the deal.

Since then, Cardiovalve has worked to advance its valve replacement device. Cardiovalve has created three valve sizes and a transseptal delivery system that it thinks will enable it to treat patients with both tricuspid and mitral regurgitation.

The mitral valve regurgitation opportunity has attracted a who’s who of big cardiovascular medical device companies. In 2015, Abbott, Edwards and Medtronic all bought their way into the space. All the acquired devices were designed for transapical delivery, which entails puncturing the heart, but Abbott later bought a transseptal option. Edwards’ device can also be delivered transseptally. 

Cardiovalve is administered transseptally, an approach that some studies have associated with better outcomes. The approach was successful in early mitral regurgitation cases, encouraging Cardiovalve to initiate clinical trials in the indication. 

In parallel, Cardiovalve has gone after the tricuspid valve replacement market, which is yet to attract as much attention from major medtechs as the tricuspid valve repair and mitral regurgitation opportunities. NaviGate Cardiac Structures, whose technology was licensed from Cleveland Clinic, is working on a bio-prosthetic atrioventricular valved stent​ to restore tricuspid function.

Cardiovalve recently gained clearance to test its device in tricuspid regurgitation. A 15-patient study is set to assess the safety and performance of the device over the first 30 days and then track the subjects for up to five years. 

As Cardiovalve advances its device in tricuspid and mitral regurgitation, it stands to benefit from the perks of the breakthrough device designation. The status positions Cardiovalve to receive extra input from FDA, an accelerated review and a streamlined reimbursement process.