News | November 12, 2007

FDA Clears PEARL 5.0 Robotic Hand Piece

November 13, 2007 - Cardiogenesis Corp., a leading developer of surgical products for transmyocardial revascularization (TMR), announced that the FDA has granted marketing approval for its PEARL (Port Enabled Angina Relief using Laser) 5.0 Robotic Delivery System, allowing TMR treatment to be performed entirely endoscopically.

Reportedly 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 lack blood supply, and works to disable chest pain or angina.

The PEARL 5.0 Robotic delivery system consists of the CrystalFlex 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.

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