Direct Flow Medical said today that it won CE Mark approval in the European Union for an additional size of its replacement heart valve, plus an EU OK for the use of the devices without contrast media.
EuroZone regulators approved the 23mm size of Direct Flow’s transcatheter aortic valve implant, expanding its valve portfolio to 23mm, 25mm, 27mm and 29mm valves, according to a press release. The devices are designed to reduce the paravalvular leakage that was a problem with earlier versions of TAVI devices and can be re-positioned "until optimal results are obtained," according to the release.
Direct Flow 1st won CE Mark approval in the European Union for its TAVI device in January 2013.
"These approvals are a testament to our continuous focus on innovation and patient outcomes. Physicians will not only be able to treat a broader patient population, but will also be able to implant this technology with no contrast and no compromises," CEO Bernard Lyons said in prepared remarks. "Our pipeline of structural heart technologies is strong and we continue to invest in new products and new indications for our unique therapeutic platform."
Contrast media have been linked with renal problems; about 22% of TAVI patients end up with acute kidney injury. Implanting the TAVI device without the need for the imaging dyes reduces that risk, Direct Flow chief medical officer Dr. Charles Davidson said in prepared remarks.
"Use of contrast during angiographic procedures is a well-documented cause of acute kidney injury," Davidson said. "By eliminating or reducing the quantity of contrast administered during TAVI, we will be able to better protect the kidneys and minimize peri-procedural complications."
In May, the FDA approved an investigational device exemption for the Salus U.S. pivotal trial of the Direct Flow TAVI device, after a 30-patient feasibility phase showed a 30-day survival rate of 97%, low procedural complications, no incidence of stroke, a 3% rate of permanent pacing and 100% of patients with mild or less aortic regurgitation.
The Salus trial’s pivotal phase will involve up to 30 sites, with a primary endpoint of composite all-cause mortality and disabling stroke at 12 months, Direct Flow said at the time.