Imperative Care's Neurovascular Access Catheters Cleared by FDA
January 23, 2019—Imperative Care, Inc. announced FDA 510(k) clearance of its first family of access catheters, which are designed to deliver interventional treatments during minimally invasive neurovascular procedures for aneurysms, stroke, and other brain blood vessel conditions.
Imperative Care’s first products are neurovascular access catheters designed to enable smooth, consistent navigation deep into blood vessels of the brain. These catheters will be launched at select centers in the United States in the coming months.
Reade De Leacy, MD, who performed the first clinical case with the device, commented in the company's release “Getting to the brain is the necessary and first step in any procedure. Imperative Care’s new access catheters are designed to provide a platform that facilitates easier navigation through complex vasculature. This should help physicians treat patients more quickly, giving them the best chance at an optimal recovery.” Dr. De Leacy is Assistant Professor of Neurosurgery and Radiology, and Site Director of Cerebrovascular Services at Mount Sinai Queens in New York, New York.
The company advised that it is also developing a pipeline of technologies designed to improve the effectiveness and speed of acute stroke treatment. The company’s near-term pipeline includes an aspiration treatment catheter designed to facilitate rapid clot removal.
In the announcement, L. Nelson "Nick" Hopkins, MD, Cofounder of Imperative Care, stated, “We are now in a brand new era in stroke treatment. The field has been revolutionized in recent years with more modern imaging modalities, therapeutic technologies, and clinical rigor identifying the importance of the timing of intervention. All of these important advancements have underscored that, as in the treatment of acute myocardial infarctions, improved mechanical solutions to physically open the blocked brain artery will continue to offer clear advantages for improved patient outcomes.” Dr. Hopkins is also Founder and Chief Scientific Officer of the Jacobs Institute in Buffalo, New York.