A Medical Device Daily

CardioMEMS (Atlanta) has raised about $22.1 million — money the medical device maker will use to help finance a major clinical trial. CardioMEMS is developing a wireless device that can be implanted into the body to manage chronic cardiovascular diseases.

The company's technology platform is designed to improve the management of severe chronic cardiovascular diseases such as heart failure, aneurysms and hypertension.

The $22.1 million, raised by existing investors, including Arcapita Ventures (Atlanta), Boston Millennia Partners (Boston) and Foundation Medical Partners (St. Nashua, New Hampshire), is part of a planned $29.5 million raise CardioMEMS is planning, according to a regulatory filing.

The financing will be used to help pay for the CHAMPION clinical trial, which is evaluating the safety and effectiveness of CardioMEMS' heart failure (HF) pressure measurement system.

The clinical trial is being conducted in more than 65 heart centers in the U.S.

The CardioMEMS wireless HF sensor is a miniature device which is implanted into the patient's pulmonary artery using a catheter-based procedure.

The pulmonary artery pressure is then measured and displayed using the CardioMEMS proprietary electronic monitoring system.

Following the procedure, patients perform wireless measurements of their pulmonary artery pressure from home. The pressure data is immediately transmitted to a secure database and available for review by the implanting physician on the CardioMEMS web site.

CardioMEMS anticipates seeking FDA approval of its Champion heart failure pressure measurement system in 2010.

In December 2007, the company raised $33 million. The company kicked off 2007 seeking an initial public offering to raise $86 million (Medical Device Daily, Jan. 23, 2007).