Clinical Studies

CarboMedics' commitment to surgeons and patients continues as we apply our technology to help people feel better at heart. CarboMedics works with physicians and medical institutions to conduct scientific studies prior to general release of a new product or therapy or to demonstrate the efficacy of a current device.

Current Clinical Study:

Mitroflow Aortic Pericardial Heart Valve

The Mitroflow aortic pericardial heart valve has been commercially available outside the United States for the past 22 years. The safety and effectiveness of the Mitroflow valve has not been proven in the United States. The goal of this study is to obtain data to support a pre-marketing application (PMA) to the U.S. Food and Drug Administration (FDA) to commercially sell the Mitroflow valve in the United States.

The study involves patients who require:

• Isolated aortic valve replacement
• Replacement of an existing aortic prosthetic valve

The Study Elements Design: Prospective, non-randomized, multi-center # Centers: Minimum of 15 # Patients / Patient-Years: Minimum of 300 patients/ 800 patient-years of follow-up Duration: Approximately 5 years

Purpose: Primary Objectives: To determine the safety and effectiveness of the Mitroflow valve after replacement of a diseased or dysfunctional native aortic valve or aortic valve prosthesis. To demonstrate the complication and survival rates for the Mitroflow valve are comparable to appropriate historical controls; To demonstrate the hemodynamic performance of the Mitroflow valve is comparable to that reported for other stented pericardial aortic bioprostheses in the current literature; and To demonstrate a clinically significant improvement in overall patient condition by comparison of preoperative and postoperative NYHA functional classifications.

If you are interested in learning more about this study, please contact CarboMedics' Clinical Department at (512) 435-3541 or 1-800-648-1579 (Press 2 for the Clinical Department) or email us at clinicalstudies@carbomedics.com

CAUTION: Investigational device. Limited by Federal law to clinical investigational use. To be used exclusively for clinical investigation by qualified clinical investigators.