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