• Cardiogenesis (Foothill Ranch, California), a manufacturer of surgical products and accessories used in angina-relieving transmyocardial revascularization and percutaneous myocardial channeling (PMC) procedures, reported it has received FDA approval, under an investigational device exemption, on the clinical trial protocol for the PMC procedure. Prior to receiving the protocol approval, the company entered into a binding letter of agreement with the FDA to ensure that key scientific and clinical issues regarding the PMC technology and trial are clearly understood and agreed to prior to commencing the study. Following receipt of the protocol approval, the company said it plans to continue its search for a strategic partner and begin the U.S. trial this year.

• SenoRx (Aliso Viejo, California) reported that it has been granted new partial breast radiation balloon patents by the U.S. Patent and Trademark Office. The patents cover products for short-term breast radiation balloons currently in development at SenoRx used to irradiate the breast tissue surrounding the cavity created following lumpectomy. The SenoRx product is designed with vacuum ports on the distal and proximal ends of the balloon, which may give physicians the ability to use suction to remove cavity fluid and air and to conform tissue to the balloon's exterior surface while delivering radiation. The system is designed for compatibility with either isotope or X-ray source-generated radiation.

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