Monday, April 22, 2024
Expanse ICE unveiled today that its ICE Aspiration System has obtained 510(k) clearance from the U.S. Food and Drug Administration. This announcement introduces a new contender in the peripheral thrombectomy market, injecting a sense of novelty and anticipation.
The ICE System is specifically crafted to tackle the intricate challenges associated with peripheral thrombectomies. Peripheral blood clots stand as the third most common vascular disease, affecting nearly one million patients annually, with up to 33% facing long-term complications, according to the Center for Disease Control.
Eitan Konstantino, PhD, an experienced entrepreneur in the vascular device field, is the driving force behind Expanse ICE. 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, stated Dr. Konstantino.
It is clear this device was built with physicians in mind. 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, said Dr. Michael Lichtenberg, Chief Medical Officer of Angiology at the Vascular Center Clinic in Arnsberg, Germany.
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, said Dr. Aravinda Nanjundappa, Director of Peripheral Vascular Interventions at the Cleveland Clinic.
The thrombectomy market is witnessing robust growth and the approval of the ICE system comes at an auspicious time. It is cutting-edge technology in an underpenetrated market, said Shlomi Nachman, former Johnson & Johnson Company Group Chairman of Cardiovascular & Specialty Solutions and Vision.
Source: prnewswire.com
