Cardiogenesis (Irvine, Califonrnia), a developer of surgical products for transmyocardial revascularization (TMR) reported FDA approval of its PEARL (Port Enabled Angina Relief using Laser) 5.0 Robotic Delivery System. Cardiogenesis said that the PEARL 5.0 is the only TMR delivery system "compatible with robotic surgical systems.

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.

Louis Brunsting, III, MD, of Centennial Medical Center (Nashville, Tennessee), principal investigator for the PEARL investigational device exemption (IDE) clinical study, noted that TMR uses laser energy delivered through a small optical fiber to create channels in heart muscle that doesn't have enough blood supply, for treating patients with Angina. "The PEARL 5.0 device now allows this form of treatment to be performed entirely endoscopically, with only a few port incisions," he said. "This new minimally invasive approach, utilizing asurgical robotic system, can markedly reduce hospitalization and recovery time for patients, facilitating their return to an active lifestyle."

"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. "We believe the PEARL 5.0 Robotic delivery system approval increases the number of patients who can be effectively treated with TMR."

TMR is for the treatment of advanced coronary artery disease in patients whose chronic angina symptoms are not relieved by medication and have an area of the heart that cannot be treated by percutaneous intervention or bypass surgery. The company says that "Three out of four patients who received TMR in studies have shown a significant reduction in their angina pain."

TMR is reimbursed by Medicare, Medicaid and most private payers when performed as a stand-alone procedure and when performed adjunctively to bypass surgery.

Founded in 1989, Cardiogenesis develops laser-based surgical products and disposable fiber-optic accessories that treat diffuse coronary artery disease.