Imperative Care announces FDA clearance of initial products


Imperative Care have announced US Food and Drug Administration (FDA) 510(k) clearance of its first family of access catheters, 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, which can be challenging because of the brain’s highly complex and twisted vascular structure. The catheters are designed to enable physicians to navigate to the treatment site with greater control and flexibility—critical to successful neurovascular procedures, where every minute counts—without sacrificing support or stability. These catheters will be launched at select centres in the USA in the coming months.

“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,” said Reade De Leacy, assistant professor of Neurosurgery and Radiology, and site director of Cerebrovascular Services at Mount Sinai Queens, who performed the first clinical case.

Imperative Care is also developing a pipeline of technologies designed to help clinicians improve the effectiveness and speed of acute stroke treatment, with the goal of enabling better patient outcomes. The company’s near-term pipeline includes an aspiration treatment catheter designed to facilitate rapid clot removal.

“We are now in a brand new era in stroke treatment. The field has been revolutionised 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,” said Imperative Care co-founder L. Nelson “Nick” Hopkins, who is also founder and chief scientific officer of the Jacobs Institute in Buffalo, New York. “Stroke no longer has to be a death or disability sentence. With new technologies, more patients will be able to return to normal lives following a stroke.”

Imperative Care is the twenty-first company co-founded by Incept LLC, a medical technology accelerator and development company that has successfully innovated various medical technologies that treat more than a million patients a year globally.


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