Nov 13 2007
Cardiogenesis Corporation, a leading developer of surgical products for transmyocardial revascularization (TMR) today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for its PEARL (Port Enabled Angina Relief using Laser) 5.0 Robotic Delivery System. The PEARL 5.0 is the only TMR delivery system compatible with robotic surgical systems.
"The Cardiogenesis TMR system uses laser energy delivered through a small optical fiber to create channels in heart muscle that doesn't have enough blood supply, thus helping patients with disabling chest pain or angina," said Louis A. Brunsting, III, M.D at Centennial Medical Center, Nashville, TN, the principal investigator for the PEARL investigational device exemption (IDE) clinical study. "The PEARL 5.0 device now allows this form of treatment to be performed entirely endoscopically, with only a few port incisions. This new minimally invasive approach, utilizing a surgical robotic system, can markedly reduce hospitalization and recovery time for patients, facilitating their return to an active lifestyle."
The PEARL 5.0 Robotic delivery system consists of the CrystalFlex(TM) fiber optic within a handpiece with an extended length flexible shaft to allow it to be introduced through small incisions in the chest wall through a 5 mm port. The end of the flexible shaft is designed to enable the grasping and manipulation of the tip by surgical robotic tools within the chest cavity for placement on the surface of the targeted area of the heart muscle. The CrystalFlex fiber optic is then advanced through the flexible shaft into the heart muscle using the handpiece control to create a series of laser channels.
"FDA approval of the PEARL 5.0 is a significant achievement for Cardiogenesis and an important advancement for patients suffering from heart disease who are not candidates for coronary stents or bypass surgery," said Richard Lanigan, President of Cardiogenesis. "Physicians can now offer the proven clinical benefits of TMR utilizing the less invasive approach via robotic surgical systems. We believe the PEARL 5.0 Robotic delivery system approval increases the number of patients who can be effectively treated with TMR."