FDA grants breakthrough nod for Rapid Medical’s embolization assist device

[Image from Rapid Medical]Rapid Medical announced today that it received FDA breakthrough device designation for its Comaneci embolization assist device.

Yokneam, Israel-based Rapid Medical designed the Comaneci embolization device to facilitate the treatment of cerebral vasospasm following hemorrhagic stroke.

In a news release, the company touted clinical results for the platform, which is already available in Europe for vasospasm intervention. In a 30-patient multi-center retrospective analysis, 97% of patients showed an increase in vessel opening of at least 25%, while 80% showed an increase of 50% or more.

Rapid Medical noted that more than 10,000 procedures have been performed worldwide with Comaneci assisting in the coil embolization of wide-neck intracranial aneurysms.

The company touts features such as an adjustable diameter, lowe delivery profile and strong visibility, with the temporary device offering a treatment modality that may prevent …

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DTW Podcast: How Josh Makower wrote the book(s) on medtech innovation

Josh Makower, MD, quite possibly invented modern day medtech innovation.

In this interview, Makower shares his earliest inventions – kind of mind-blowing – and how his early work at Pfizer helped him create the innovation process used today by biodesign programs across the world, including Stanford Biodesign where Dr. Makower will take over as director this fall.

This interview is essential for any individual or organization that wants to innovate. Dr. Makower will share his thoughts on how innovation in any industry should be approached.

This week we’ll explore innovation and social equity. We’ll hear a portion of an interview with Martha Ha, chief privacy officer and chief counsel of corporate governance, and Jon de Csepel, CMO, vice president, medical affairs of the Americas. The pair will explain how the company is reaching out to employees of Asia and Pacific Island and helping them to understand how to better work within the corporate culture. The …

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