• Cardiogenesis (Foothill Ranch, California), a developer of surgical products and accessories used in angina-relieving procedures, submitted its definitive percutaneous myocardial channeling (PMC) trial protocol to the FDA in an investigational device exemption application. It expects to receive formal response from the FDA regarding the submission within 30 days, and to be able to begin this trial in the U.S. in eligible patients suffering from severe angina soon thereafter. In early June, Cardiogenesis received a letter of agreement from the FDA that detailed its acceptance of the key elements of trial design, endpoints and patient criteria that forms the basis of the PMC trial protocol. PMC is CE-marked in Europe.
• CAS Medical Systems (Branford, Connecticut) said acceptance of an abstract showing initial validation of its cerebral oximeter for presentation at the American Society of Anesthesiologists’ (ASA) annual meeting in October. The abstract details the performance of the new CAS monitor on healthy volunteers in a study conducted by Duke University Medical Center (Durham, North Carolina). Data from this study was also presented at the recent Duke Cardiothoracic and Regional Update in Hilton Head Island, South Carolina. The CAS cerebral oximeter uses the company’s Near Infra-Red Spectroscopy technology, a non-invasive, optically based technique, to monitor brain oxygenation continuously by determining absolute cerebral tissue oxygen saturation. In combination with pulse oximetry, the CAS monitor may be used to estimate the cerebral venous oxygen saturation. Results show that the CAS cerebral oximeter shows a high level of accuracy and consistency when compared to reference co-oximetry measurements. The data from this study has been submitted to the FDA as part of the company’s 510(k) premarket notification.
• Dermisonics (West Conshohocken, Pennsylvania), which is developing an ultrasonically assisted transdermal drug-delivery technology, reported that the U.S. Patent and Trademark Office issued the first patent to the company, U.S. patent No. 6,908,448, titled “Substance delivery device.” The patent addresses the most substantial patent claims for the ultrasonic patch cap and a flexible patch for the transdermal delivery of drugs via ultrasound. This is the first of the company’s patents to issue, while 11 more remain pending and active, both domestically and internationally.