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Imperative Care wins FDA nod for stroke catheter

July 17, 2024 By Sean Whooley

Imperative-Care-Zoom-Stroke-Solution
The Zoom stroke solution. [Image courtesy of Imperative Care]
Imperative Care announced today that the FDA granted 510(k) clearance for its Zoom 6F insert catheters for ischemic stroke procedures.

The company also announced the successful completion of the first case with the Zoom 6F insert catheters. Dr. Dana Tomalty performed the case at Huntsville Hospital in Huntsville, Alabama.

Tomalty used the catheter to quickly select the target vessel and provide intracranial access from the femoral artery in a patient with a challenging anatomy and distal left M2 occlusion. Tomalty then aspirated and removed the clot in just 10 minutes from puncture to reperfusion. This resulted in a complete TICI 3 revascularization.

“In my experience, navigating the aortic arch can pose a significant challenge in patients with more tortuous anatomy. Due to the unique design and capabilities of the Zoom 6F insert catheters, I believe the use of these technologies will help mitigate this challenge and take minutes off my stroke thrombectomy times, allowing me to get the clot out faster,” Tomalty said in a news release.

A look at the Imperative Care Zoom 6F catheters

Campbell, California-based Imperative Care says it’s Zoom 6F catheters are the first insert catheters developed specifically for ischemic stroke procedures. The company developed them to provide more support, torque and length than current vessel selection devices.

Offered in three stroke-specific shapes, the features deliver faster vessel selection and uncompromised delivery of intracranial access technologies. Imperative Care offers the Zoom 88, Zoom 88 Support and Zoom RDL 0.088″ solutions for access to the intracranial anatomy.

The Zoom 6F insert catheter portfolio features the Zoom SIM, Zoom VRT and Zoom VTK technologies. All offer unique shape, construction and length to help achieve faster, reliable intracranial access in a broad range of patient anatomies.

“Insert catheters used for stroke today are diagnostic catheters that were designed for cardiovascular access more than 30 years ago. The Zoom 6F Insert Catheters bring physicians the modern-day tools and technologies that will allow them the opportunity to best care for their patients, bridging the innovation gap of 30 years to today’s standards for stroke treatment,” said Ariel Sutton, GM of Imperative Care’s Stroke Business. “The introduction of the Zoom 6F Insert Catheters demonstrates our core tenet of clinical partnership, which puts the perspectives of front-line physicians at the center of our research and development process.”

Filed Under: 510(k), Applications, Catheters, Neurology, Regulatory, Technologies & Devices Tagged With: Imperative Care

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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