Expanse Ice Receives FDA 510(k) Clearance for ICE Aspiration System for Peripheral Arterial, Venous Systems

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Technology designed to effectively address blood clots by combining capabilities of larger devices with smaller catheters.

Vasoconstriction, clot formation in blood vessel. Image Credit: Adobe Stock Images/Dr_Microbe

Image Credit: Adobe Stock Images/Dr_Microbe

Expanse ICE announced that its ICE Aspiration System has received 510(k) clearance from the FDA. According to the company, the system treats venous thromboembolism (VTE), which affects nearly one million patients annually in the United States, with 33% experiencing long-term complications. The ICE Aspiration System works by combining proficiencies of larger devices with the slender profile of smaller catheters to improve ease of use.1

"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 Michael Lichtenberg, MD, FESC, chief medical officer, angiology, Vascular Center Clinic, Arnsberg, Germany, in a press release.

According to the Centers for Disease Control and Prevention(CDC), the number of people in the United States who suffer blood clots typically ranges anywhere from 350,000 to 900,000 cases per year, with an estimated 100,000 to 300,000 of those dying as a result. However, these numbers remain inaccurate due to data being taken from studies in counties that are not representative of the total US population, according to the CDC. To achieve a better understanding of the occurrence of VTE in Oklahoma County, the CDC funded a study conducted by the College of Public Health at the University of Oklahoma Health Sciences Center.2

“Currently, there is no national monitoring system for VTE, making it difficult to understand the true burden of VTE in the United States,” reports the CDC. “The methods and results of this project will help inform future efforts to develop valid U.S. estimates of VTE burden and will help guide VTE prevention efforts. The findings from this project will help researchers establish valid estimates of the number of people affected by VTE in Oklahoma County (including associated rates of illness and death), describe characteristics of the affected population and their VTE events, and characterize current VTE prevention efforts.”

The National Blood Clot Alliance(NBCA)reports that 274 people die from blood clots on a daily basis, with annual numbers being greater than those of AIDS, breast cancer, and motor vehicle crashes combined. According to NBCA statistics, fewer than one in four people have any recognition of blood clots or their signs and symptoms. Provoked blood clots, which are an estimated 70% of all blood clot patients, are associated with typical risk factors. On the contrary, unprovoked blood clots, which account for the remaining 30%, don’t have an identifiable risk factor.3

"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, cardiovascular & specialty solutions and vision, in the press release.

References

1. Innovative Aspiration Thrombectomy System by Expanse ICE Receives FDA Clearance for vessels of the peripheral arterial and venous systems. PR Newswire. April 22, 2024. Accessed April 22, 2024. https://www.prnewswire.com/news-releases/innovative-aspiration-thrombectomy-system-by-expanse-ice-receives-fda-clearance-for-vessels-of-the-peripheral-arterial-and-venous-systems-302122988.html

2. CDC project informs efforts to understand and monitor number of people affected by blood clots in US. CDC. June 28, 2023. Accessed April 22, 2024. https://www.cdc.gov/ncbddd/dvt/features/keyfinding-bloodclots-vte.html#:~:text=The%20actual%20number%20of%20people,is%20from%20100%2C000%20to%20300%2C000.

3. BLOOD CLOTS IN THE UNITED STATES. National Blood Clot Alliance. Accessed April 22, 2024. https://www.stoptheclot.org/blood-clot-information/blood-clots-in-the-united-states/

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