Direct Flow Medical today said it’s putting an enhanced delivery system for its replacement heart valve on the European market after it won CE Mark approval for use in patients at extreme risk for open heart surgery.
Santa Rosa, Calif.-based Direct Flow said the enhanced transfemoral delivery system for its transcatheter aortic valve implant features an ergonomic handle designed for easy, precise and controlled delivery of the valve and includes a low-profile, flexible sheath for easy access and better tracking through calcified tissue.
Direct Flow now has a valve portfolio that can treat patients with annulus sizes from 19mm to 28mm, according to a press release.
"Direct Flow Medical continues to innovate with the focus on improving patient outcomes. The approval of the enhanced Direct Flow Medical delivery system is further evidence of our commitment to the medical community that treats TAVI patients," chief medical officer Dr. Charles Davidson said in prepared remarks. "We continue to deliver on our promise to develop innovative products delivering the best patient outcomes, and continue to investigate new indications for our unique therapeutic platform.”
Direct Flow 1st won CE Mark approval in the European Union for its TAVI device in January 2013. The company won FDA approval for a pivotal trial in May. The 30-patient feasibility phase of Direct Flow’s Salus trial last year showed a 30-day survival rate of 97%, low procedural complications, no incidence of stroke, a three% rate of permanent pacing and 100% of patients with mild or less aortic regurgitation, according to a press release.