Alleviant Medical Inc., a privately-held medical device company, today announced that the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its transcatheter technology. The technology 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.
The Breakthrough Device Program creates a pathway for patients to have more timely access to innovative medical devices by expediting their development, assessment, and review while preserving the statutory standards for premarket approval. The Centers for Medicare and Medicaid Services (CMS) recently finalized a new coverage pathwayfor Breakthrough Devices, the Medicare Coverage of Innovative Technology (MCIT). The MCIT coverage policy facilitates patient access to Breakthrough Devices by providing up to 4 years of Medicare coverage beginning on the date that FDA clears or approves a Breakthrough Device.
“Chronic heart failure affects more than 26 million patients globally and HFpEF patients in particular have limited treatment options,” said Adam L. Berman, CEO of Alleviant Medical. “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.”
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.”