JenaValve recalls certain TAVR delivery catheters over safety concerns
JenaValve is recalling specific lots of the delivery catheter associated with its Trilogy Transcatheter Heart Valve System. This includes 111 units for the 23-mm Trilogy device, 108 units for the 25-mm Trilogy device, and 143 units for the 27-mm Trilogy device.
This recall was initiated due to a fear that the delivery catheter may have “sleeve liner separation” that makes it challenging—or even impossible—to be properly deployed. The U.S. Food and Drug Administration (FDA) has categorized this as a Class II recall, which means using these devices “may cause temporary or medically reversible adverse health consequences.”
The Trilogy transcatheter heart valve features a self-expanding nitinol frame, an open-cell design that enables future coronary access and locators placed with commissural alignment in mind. In March, it became the first transcatheter heart valve approved by the FDA for performing TAVR to specifically treat aortic regurgitation (AR). This approval gained even more significance when the U.S. Centers for Medicare and Medicaid Services (CMS) announced it was considering updating its national coverage determination (NCD) for TAVR so that Medicare covers TAVR in patients with AR. CMS has not yet made a final decision.
The Trilogy’s delivery catheter is part of the device's delivery system, which was built to provide clinicians with single-action valve deployment during minimally invasive implant procedures. Clinicians are able to center the valve above the annulus, rotating it as needed until the positioning is finalized.
The Trilogy Delivery System. Image courtesy of JenaValve.
What should customers do?
Customers with any of these delivery catheters in their inventory should immediately quarantine them. JenaValve will schedule a visit to retrieve the devices.
It is worth noting that this Class II recall only includes certain lots of JenaValve product.
For the 23-mm device, the lots are: DS-042326-003, DS-042726-006, DS-042826-005, DS-050426-007, DS-050626-002, DS-050626-006, DS-050626-009 and DS-050726-005.
For the 25-mm device, the lots are: DS-040826-005, DS-040926-002, DS-042326-001, DS-042826-007, DS-042926-008, DS-050826-005 and DS-051526-001
For the 27-mm device, the lots are: DS-040926-004, DS-041026-008, DS-041026-009, DS-042226-006, DS-042226-007, DS-051526-004, DS-051526-006, DS-060226-007, DS-060526-002, DS-060526-003 and DS-060526-007.
Click here for more information from the FDA.
Cardiovascular Business has reached out to JenaValve for comment.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.