US-based medical technology company Imperative Care has received the US Food and Drug Administration (FDA) 510(k) approval for its Zoom 6F Insert Catheters to enhance stroke care.

According to Imperative Care, Zoom 6F represents the first insert catheter portfolio specifically developed for ischemic stroke procedures, based on physician feedback.

The portfolio includes the Zoom SIM, Zoom VRT, and Zoom VTK technologies, with unique shapes, construction, and length, to help physicians achieve faster intracranial access.

Imperative Care said that its catheters are designed to be more supportive, more torque-able and longer than current vessel selection devices.

They enable faster vessel selection and delivery of its 0.088” intracranial access technologies, Zoom 88, Zoom 88 Support and Zoom RDL, said the medical technology company.

Imperative Care stroke business general manager Ariel Sutton said: “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.

“We are deeply committed to working closely with physicians to identify critical gaps in stroke care and providing innovative solutions that bring meaningful benefits to their patients.”

The first procedure using the Zoom 6F Insert Catheters was completed at Huntsville Hospital in Huntsville, Alabama, in a patient with a challenging anatomy and distal left M2 occlusion.

Dr. Dana Tomalty performed the procedure, using Zoom SIM Insert Catheter to select the target vessel and provide .088” intracranial access from the femoral artery with Zoom 88.

The Zoom SIM offered additional stability to navigate Zoom 88 deep into the brain and access the clot more quickly.

Dr. Tomalty then used both Zoom 71 and Zoom 35 to aspirate and remove the clot within 10 minutes from the puncture to reperfusion, completing the TICI 3 revascularisation.

Tomalty said: “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.”