Alleviant said FDA has granted the company a Breakthrough Device designation for its transcatheter technology.
The Austin, TX-based company said the device offers a no-implant interatrial shunt therapy for patients suffering from heart failure with preserved (HFpEF) and mid-range ejection fraction (HFmrEF) who remain symptomatic despite optimal guideline-directed medical therapy.
“Chronic heart failure affects more than 26 million patients globally and HFpEF patients in particular have limited treatment options,” Adam Berman, CEO of Alleviant Medical, said in a release. “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. We appreciate the rigorous review by the FDA and their designation of our technology as a Breakthrough Device. We look forward to the ongoing constructive collaboration as we continue to develop clinical evidence.”
In a release, Chief Medical Officer and co-Founder Jacob Kriegel, MD commented, “Current pharmaceutical options for treating HFpEF/HFmrEF are limited, and patients stand to benefit from additional innovative device therapies. Our technology enables the creation of a therapeutic interatrial shunt, intended to offload elevated left atrial pressure in properly indicated HFpEF/HFmrEF patients, without the need for a permanent cardiac implant. 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.”