A Medical Device Daily

Cardiogenesis (Irvine, California), a provider of surgical products and accessories used in angina-relieving procedures, reported Friday that it has submitted a pre market approval (PMA) supplement to the FDA for its minimally invasive Robotic 5.0 PEARL (Port Enabled Angina Relief using Laser) delivery system.

The Robotic PEARL 5.0 delivery system is designed for operation through a 5.0 mm port by Intuitive Surgical's (Sunnyvale, California) da Vinci surgical system. All procedures included in the PMA supplement were performed with the da Vinci system. No patient deaths were reported in the operative (30 day) period.

Regarding this achievement, Richard Lanigan, president of Cardiogenesis said, "We are excited to have completed the IDE study of our Robotic PEARL delivery system. We have submitted the safety, feasibility and analysis results of the patients who received TMR [Transmyocardial Revascularization] treatment with our system. We look forward to working with the FDA on this PMA supplement submission during their 180-day review period in anticipation of FDA approval for commercial release."