FDA OKs Imperative Care’s Zoom 7X Catheter for Ischemic Stroke

Imperative Care has received U.S. Food and Drug Administration (FDA) 510(k) clearance and completed the first cases with its Zoom 7X catheter for aspiration thrombectomy procedures.

The Zoom 7X catheter is the first to incorporate CenTRX technology, a 96-degree, pre-shaped tip designed to center in the vessel, maximizing clot ingestion with the asymmetric tip’s extra surface area. This feature lets the device navigate challenging anatomy and self-orient the geometric tip into the best position for full clot aspiration.

Dr. Jacob Cherian, M.D., University of Maryland said he’s seen significant benefit in using a shaped asymmetric tip for his stroke procedures. Dr. Cherian said he believes Zoom 7X’s tip allows the catheter to self-orient from within the vessel’s center for better trackability.

This capability, along with a full system approach from .088” intracranial access to complete clot ingestion, has helped further streamline my procedures,” Dr. Cherian told the press. “I’m encouraged to see Imperative Care respond to feedback from the physician community to engineer a solution that I expect will bring notable improvements to procedure efficiency and speed.”

The Zoom system is designed to be a complete stroke system from access through reperfusion for fast and effective clot removal in patients presenting with acute ischemic stroke. Imperative Care’s Zoom System consists of the Zoom 35, 45, 55, 71 and 7X Catheters, Zoom 88 Large Distal Platform, Zoom 88 Support, Zoom POD and Zoom Aspiration/Zoom POD tubing, Zoom Canister and DuoPort Canister.

“Based on direct feedback from physicians, the Zoom 7X Catheter was developed to address the need for even greater trackability, navigation and asymmetric clot ingestion,” said Ariel Sutton, General Manager of Imperative Care Stroke. “Zoom 7X builds upon our comprehensive system of stroke technologies with the goal of making the procedure faster, safer and more efficient than ever before. The launch of Zoom 7X, paired with the recent introduction of the Continuous Dual Aspiration Technique (CDAT) with Zoom DuoPort, advances the field one step closer to making TICI 3 in 10 minutes the expectation for physicians.”

Earlier this month, Imperative Care began a partnership with Proximie to drive development of a robotic surgical system to treat ischemic stroke.