FDA authorizes Pi-Cardia’s valve-in-valve TAVR device

Dive Brief:

Pi-Cardia received Food and Drug Administration clearance for a device designed to reduce the risk of coronary obstruction in valve-in-valve transcatheter aortic valve replacement (TAVR) procedures.
When a TAVR device fails, physicians can perform a valve-in-valve procedure to fix the problem without repeat or open-heart surgery. However, the procedure can raise the risk of blockages that restrict blood flow to the heart.
Pi-Cardia, which announced its clearance on Sept. 30, designed its Shortcut device to mitigate the risk of coronary artery obstruction by splitting aortic valve leaflets before valve placement. The FDA granted Shortcut with its breakthrough device designation in January.

Dive Insight:

Use of TAVR devices in younger patients with a longer life expectancy has raised concerns that valves could fail within the lifetimes of recipients. Valve-in-valve replacement allows physicians to fix the problem without repeat surgery. Larry Wood, group president of TAVR and surgical structural heart at Edwards Lifesciences, said at an investor event in December that he expects “valve-in-valve to be an increasing contributor over time.”

The downside to the valve-in-valve procedure is the risk of blockages. The leaflets of the failing valve stay in place and, if they are displaced, can cause coronary obstruction. One study found around 2.6% of people had obstructions during valve-in-valve TAVR, but the rate was as high as 7% for some devices.

The National Institutes of Health developed a device called Basilica to address the problem and reported first-in-human data in 2018. Pi-Cardia’s Shortcut differs from Basilica in that it uses a blade, rather than electrosurgery, to mechanically split leaflets. The authors of a paper on Shortcut’s first-in-human study said Basilica is effective but “requires highly skilled and experienced operators.”

Martin Leon, director of the Center for Interventional Vascular Therapy at New York-Presbyterian, said in a statement that the pivotal Shortcut study showed the procedure was “controlled and teachable.” The findings mean the procedure is adoptable “as a critical step pre-implantation, so that patients at risk of coronary obstruction may be safely treated, without disruption of TAVR workflow,” said Leon, who chairs the global steering committee for Shortcut studies.

Pi-Cardia is building a commercial and clinical support team to handle a limited launch of the device. The company said planned expansions into native and bicuspid valves may mean around 30% of future TAVR cases require leaflet modification to safely obtain optimal results.