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Mirador Biomedical Submits 510(K) Application For Compass Vascular Access Medical Device


7/8/2010 11:37:10 AM

Seattle, WA – July 8, 2010 – Mirador Biomedical, Inc. announced today that it has filed a 510(k) application with the U.S. Food and Drug Administration (FDA) requesting market clearance for the Compass™ Vascular Access, a medical device designed to provide quantitative pressure measurements during the insertion of central venous catheters.

Over six million central venous catheters are inserted in the US every year, and thousands of patients suffer severe injuries, stroke, or death when these catheters are mistakenly inserted into arteries. The pressure difference between veins and arteries is significant, and recent clinical evidence demonstrates that pressure measurement can help avoid these errors. Unfortunately, technical challenges associated with current pressure measurement techniques have prevented widespread adoption. The Compass™ Vascular Access is an inexpensive, single-use pressure transducer with integrated digital display designed specifically for central venous catheter insertion. The Compass VA integrates seamlessly with standard insertion techniques and enables physicians to simultaneously view their hands, the patient and the pressure without additional cabling, operators or connections.

“We’re seeing more and more hospitals mandate pressure monitoring to confirm venous access and avoid arterial cannulation. Central line checklists provided by national organizations like the Institute for Healthcare Improvement now include pressure measurement,” said Dr. Hulvershorn, Chief Science Officer of Mirador Biomedical. “The Compass Vascular Access has been well received by our physician panels because the device is so easy to use, and doesn’t add complexity, additional steps, or time to the procedure.”

Karl Schmidt, CEO of Mirador Biomedical added, “Our 510k application represents an important milestone for the company and a significant step toward the commercialization of a unique product that physicians are demanding. In our conversation with physicians we were repeatedly told that using pressure to help confirm correct catheter placement is becoming the standard of care, but current techniques are too time-consuming and problematic to perform regularly. The Compass VA has been designed to overcome these objections and we look forward to working with the FDA, physicians and partners to make our solution widely available.”

About Mirador Biomedical Mirador Biomedical’s team of experienced entrepreneurs and seasoned medical device professionals are partnering with an exceptional group of physicians and scientists to develop innovative, cost effective devices that provide physiological feedback to alleviate doubt and uncertainty during common medical procedures.

Mirador Biomedical is a privately held company founded in 2009 in Seattle, Washington to develop the Compass™ family of medical devices. The lead product, the Compass Vascular Access, is a sterile, inexpensive, single-use device with an incorporated digital display designed to provide quantitative pressure measurements during the insertion of central venous catheters. The device integrates seamlessly with current procedural techniques and enables physicians to simultaneously view their hands, the patient and the pressure without additional cabling, operators or connections. For more information, visit www.miradorbiomedical.com



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