Background
The Houdini Catheter by Cruzar Medsystems is a balloon catheter for guidewire placement in the most difficult to cross vascular obstructions. Sirius Engineering worked with Cruzar Medsystems from early incubation and development, obtaining regulatory approvals, and manufacturing the Houdini product that is on the market today.
The Magic of HouDini
In 2013 Michael Glennon, the CEO of Cruzar Medsystems was looking for a solution to a problem he had identified in the surgical ward. He realized that a lot of time was spent simply trying to get around obstructed vessels. He needed a technical partner to help him develop a solution. After meeting with Tom Kramer, the founder of Sirius Engineering, and Dr. Al Chin who provided a unique solution, Michael Glennon realized that Sirius would be the perfect partner.
Early prototypes are often crude and double or triple the size of the final product.
Phase 1: Proof of concept
Sirius provided the R&D for Cruzar Medsystems by developing early prototypes. Through this work, Sirius learned that this problem could be solved by the use of a balloon anchoring system and an everting (unfolding) balloon to push and force a guide wire through an obstruction
Phase 2: feasibility
From there, we refined the Houdini Catheter into a manufacturable design by selecting materials, suppliers and began production of the assembly line. We established the Cruzar Quality System in preparation for verification and validation testing for submission to the FDA.
Phase 3: Qualification
We initiated pilot production, and performed process & sterilization validation, biocompatability testing, and Verification & Validation. On the regulatory side, we prepared/submitted the 510k and worked with the FDA to receive 510k clearance in five months.
Phase 4: Design transfer
After getting regulatory approval, Sirius Engineering delivered the first three months inventory to Cruzar for market launch. We continue to manufacture the Houdini and develop next generation devices for Cruzar Medsystems.