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Alleviant Medical wins FDA breakthrough device designation for transcath heart failure treatment

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Alleviant MedicalAlleviant 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.

 

 

About Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at cnewmarker@wtwhmedia.com.