The ICE Aspiration System has been particularly engineered to tackle the intricate challenges associated with peripheral thrombectomies
Expanse ICE’s ICE Aspiration System obtains FDA 510(k) clearance. (Credit: DIGITALE on Unsplash)
Expanse ICE has officially forayed into the peripheral thrombectomy market by securing 510(k) clearance from the US Food and Drug Administration (FDA) for its ICE Aspiration System.
The ICE Aspiration System has been engineered particularly to tackle the intricate challenges linked with peripheral thrombectomies.
Peripheral blood clots rank as the third most prevalent vascular disease, affecting nearly one million patients annually. According to the Center for Disease Control, up to 33% of these patients endure long-term complications.
Cleveland Clinic peripheral vascular interventions director Aravinda Nanjundappa said: “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.”
Expanse ICE was born from Expanse Medical, a medical device incubator established by Eitan Konstantino, a serial entrepreneur specialising in the vascular device sector.
Konstantino said: “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.”
The team behind the Expanse ICE system has also developed AngioSculpt, Chocolate, and several other neurovascular products. Expanse Medical maintains a dedicated focus on creating solutions for vascular diseases.
Earlier this year, Innova Vascular, a US-based medical device company, reported the successful initial commercial application of its Laguna Thrombectomy System in patients, with positive feedback from physicians. Consisting of two distinct devices, the Malibu Aspiration Catheter System and the Laguna Clot Retriever System, the system obtained FDA 510(k) clearance in 2023.