An innovative implant-free technology may help individuals with chronic heart failure. According to the CDC, 6.2 million adults in the U.S. have heart failure. In 2018, about 13.4% of death certificates mentioned heart failure. Current pharmaceutical options for treating heart failure is limited, and patients may benefit from additional device therapies.
On January 25, 2021 the US Food and Drug Administration (FDA) granted Alleviant Medical, a privately held medical device company, a Breakthrough Device designation for their new no-implant transcatheter technology.
Alleviant’s new technology offers an option for a simple, minimally-invasive procedure for congestive heart failure patients. The procedure is designed to use the transcatheter technology to decompress the left atrium without a permanent cardiac implant, under the guidance of ultrasound and fluoroscopy (x-ray) without open-heart surgery.
This Breakthrough Device designation may provide up to 4 years of Medicare coverage beginning on the date that FDA clears or approves a Breakthrough Device. The Centers for Medicare and Medicaid Services (CMS) recently approved a new coverage pathway for Breakthrough Devices, the Medicare Coverage of Innovative Technology (MCIT). This provides patients with more timely access to innovative medical devices.
Alleviant Medical is currently developing clinical evidence through investigational use of this novel therapy. The company plans to report outcomes from its initial patient series later in 2021.