Alleviant Medical (Austin, Texas) has received FDA breakthrough device designation for its no-implant, interatrial shunt technology for treating certain types of chronic heart failure.
Founded in 2017, Alleviant’s minimally invasive transcatheter tech decompresses the left atrium without a permanent cardiac implant or open-heart surgery. Alleviant developed the teach to treat people who have heart failure with preserved (HFpEF) and mid-range ejection fraction (HFmrEF) — and remain symptomatic despite optimal guideline-directed medical therapy.
HFpEF patients have limited treatment options, according to Alleviant Medical CEO Adam L. Berman.
“By utilizing a no-implant interatrial shunt approach, the Alleviant Medical technology offers the option for a simple, minimally-invasive procedure for heart failure patients,” Berman said in a news release.
The breakthrough device designation will enable expedited development, assessment and review from FDA, as well as access to a new CMS coverage pathway.
“We are currently developing robust clinical evidence through investigational use of this novel therapy and look forward to reporting outcomes from our initial patient series later this year,” said Dr. Jacob Kriegel, Alleviant Medical’s chief medical officer and co-founder.