Medical device maker Direct Flow Medical unveiled 30-day results for its namesake transcatheter aortic valve implantation system, touting reduced valve leakage and procedure-related complications for the inflatable device.
In the study, which will enroll up to 100 patients, Direct Flow’s TAVI met primary mortality endpoints with zero incidents of major vascular complications and with 95% of patients experiencing mild or less paravalvular regurgitation.
Valve leakage, which can lead to aortic regurgitation, is one of the chief challenges with 1st-generation TAVI systems and one that many next-generation devices are looking to address.
"We are pleased to report the positive initial results for the Direct Flow Valve, as it resolves one of the most important clinical issues in the TAVR market today – aortic regurgitation," principal investigator Dr. Joachim Schofer said in prepared remarks. "In the trial, we also found that the device was easy to use, offered maximum control and resulted in precise placement. This novel device has the potential to improve clinical outcomes globally and better serve the needs of a growing patient population."
Medtech giant Medtronic(NYSE:MDT) earlier this month reported results from its early results from the pivotal CE Mark trial of its Engager TAVI system, touting reduced valve leakage and easier device deployment. Similar reports came from an early feasibility study of Boston Scientific’s (NYSE:BSX) Lotus transcatheter aortic valve implantation, which also showed precise positioning on the 1st attempt and almost compete obliteration of aortic regurgitation, according to investigators.
Direct Flow hopes to hold its own against its larger rivals with its TAVI system, which features an inflatable cuff and polymer support structure. The device has no metallic frame, unlike the rival devices, and can be repositioned in the body even after full expansion, according to a press release.
Direct Flow’s study enrolled patients with severe aortic stenosis who were at extreme risk for open surgery, with the newly released results including the 1st 33 patients.
All patients were treated transfemorally, with no deaths at 30 days. Valve leakage was mild or better in 97% of patients, and non-existent or at trace levels in 81%, with measurements provided by an independent imaging core lab, according to a press release.
There were 2 strokes and 1 mild myocardial infarction among the 33 patients, whose average age was 83 years old.