Medtronic tricuspid valve replacement device wins FDA breakthrough status

Dive Brief:

Medtronic on Wednesday simultaneously announced FDA breakthrough device designation and kickoff of an early feasibility study for a transcatheter tricuspid valve replacement (TTVR) system. It's the same device, called Intrepid, that Medtronic began trialing in mitral regurgitation patients in 2017.
The development comes as competitors Abbott and Edwards Lifesciences earlier this year made new strides in commercializing devices to treat tricuspid regurgitation, winning CE marks for their valve repair devices TriClip and Pascal within months of one another. While tricuspid valve repair is generally viewed as a less risky procedure than valve replacement, not all faulty tricuspid valves can be repaired
Medtronic's replacement system is still a long way off from commercialization, but Edwards may be a bit closer. Edwards is slated to begin a pivotal study of its Evoque transcatheter tricuspid valve replacement system next month, according to a ClinicalTrials.gov listing.

Dive Insight:

Tricuspid valve regurgitation occurs in an estimated 2 million people in the U.S. who experience blood leaking backward through the valve when the right ventricle contracts. Medtronic's device is intended for patients with a severe, symptomatic form of the condition, which can lead to heart failure and death.

Medtronic almost a decade ago launched an annuloplasty ring device to help treat tricuspid valve disease. But otherwise, the company's structural heart unit has been more focused on opportunities in treating aortic stenosis, namely its transcatheter aortic valve replacement (TAVR) devices.

While opportunities to treat aortic and mitral valve disease have been saturated by Medtronic, Abbott, Edwards, Boston Scientific and others, tricuspid valve repair and replacement options are a little further behind in the commercialization process.

Medtronic's small feasibility study aims to enroll 15 participants for the self-expanding bioprosthetic valve, which is delivered through the transfemoral vein.

"The clinical experience generated during this initial study phase will be critical for the future of the therapy, as many of these patients are not good candidates for traditional surgical tricuspid valve interventions due to their poor right heart functions and are higher risk due to co-morbidities," said co-principal investigator Vinayak Bapat, chief of cardiothoracic surgery at the Minneapolis Heart Institute.

Medtronic's breakthrough device status may help expedite development and FDA review of the product, but if the small fraction of designated devices that have made it to market so far are any indication, it's far from a near-term marketing guarantee.

Israel-based medtech startup Cardiovalve beat Medtronic to the punch by more than six months, having received breakthrough device designation and FDA's OK for an early feasibility study in February for the same type of device.