Expanse ICE’s Innovative Aspiration Thrombectomy System Cleared by FDA

April 22, 2024—Expanse ICE announced that its ICE aspiration system has received FDA 510(k) clearance for the peripheral thrombectomy market.

The device features a dual-lumen design that creates the company’s Surge Aspiration technology, a type of cyclic aspiration at the distal end of the catheter. The ICE system is specifically designed to address the complex challenges associated with peripheral thrombectomies.

“It is clear this device was built with physicians in mind,” commented Michael Lichtenberg, MD, in the company’s press release. “It aims to address some of the biggest issues we see regularly. The device was designed and built with a strong understanding of foundational physics that leaves me optimistic for its success.” Dr. Lichtenberg is Chief Medical Officer of Angiology at the Vascular Center Clinic in Arnsberg, Germany.

Aravinda Nanjundappa, MD, added, “I am looking forward to being among the first users of the Expanse ICE system. Its ability to offer powerful clot removal in a compact size is an intriguing proposition that could significantly enhance our ability to meet patient needs more effectively and improve treatment outcomes in peripheral vascular disease.” Dr. Nanjundappa is Director of Peripheral Vascular Interventions at the Cleveland Clinic in Cleveland, Ohio.

Expanse ICE was born from Expanse Medical, a medical device incubator founded by Eitan Konstantino, PhD. The company noted that the team responsible for the Expanse ICE system also built AngioSculpt, Chocolate, and other neurovascular products.

“We’ve engineered the ICE catheter system to harness the aspiration power typical of a large bore catheter, but within the slender profile of a much smaller device,” commented Dr. Konstantino in the company’s press release.