CARDIOVASCULAR IMPLANTS

Circle Medical Devices has special expertise in the design, testing and clinical production of cardiovascular (CV) implants.  Designing CV implants requires experience, a thorough knowledge of biomaterials, and a heightened sensitivity to acute and long- term safety issues.   We have extensive experience in designing and building sophisticated test fixtures that accurately model cardiac anatomy, blood flow and pressure.  This two barreled approach, using both ex-vivo hearts and carefully designed bench test models, provides an effective way to refine designs. 

Circle makes device safety the highest priority in the design process.  Our Risks and Hazards Analysis is separated into 3 separate parts:  Clinical Application FMECA, Design FMECA and Process FMECA.  This clear differentiation improves the analytical process by sharpening the focus on each type of FMECA.  For the Clinical Application FMECA, the Circle Quality System requires the participation of physicians as well as client representatives and the Circle design and quality teams.

Circle also has experience in developing specialized delivery devices for implants.  These delivery devices include single and dual plane deflectable guide catheters, delivery catheters with integrated sensors, adjustment tools and surgical templates.