Sam Brusco, Associate Editor01.25.21
The U.S. Food and Drug Administration (FDA) has granted Alleviant Medical Breakthrough Device designation for its transcatheter technology. It consists of a no-implant interatrial shunt therapy for patients with heart failure with preserved (HFpEF) and mid-range ejection fraction (HFmrEF) who are symptomatic despite optimal guideline directed therapy.
The Centers for Medicare and Medicaid Services (CMS) recently finalized a new coverage pathway for Breakthrough Devices, the Medicare Coverage of Innovative Technology (MCIT). The MCIT coverage policy facilitates patient access to Breakthrough Devices by offering up to four years of Medicare coverage commencing on the date 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,” Adam L. Berman, CEO of Alleviant Medical said in a press 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.”
Chief medical officer and co-founder Jacob Kriegel, M.D. also 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.”
The Centers for Medicare and Medicaid Services (CMS) recently finalized a new coverage pathway for Breakthrough Devices, the Medicare Coverage of Innovative Technology (MCIT). The MCIT coverage policy facilitates patient access to Breakthrough Devices by offering up to four years of Medicare coverage commencing on the date 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,” Adam L. Berman, CEO of Alleviant Medical said in a press 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.”
Chief medical officer and co-founder Jacob Kriegel, M.D. also 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.”