The First Minimally Invasive TMR Device Now Commercially Available to Treat
Severe Heart Disease
IRVINE, Calif., Nov. 13 /PRNewswire-FirstCall/ -- Cardiogenesis Corporation (OTC: CGCP.PK), 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."
About Transmyocardial Revascularization (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. Three out of four patients who received TMR in studies have shown a significant reduction in their angina pain. Additionally, patient benefits have been shown to endure beyond five years, and TMR has been shown to help patients live longer. TMR is reimbursed by Medicare, Medicaid and most private payers when performed as a stand alone procedure and when performed adjunctively to bypass surgery.
About Cardiogenesis Corporation
Founded in 1989, Cardiogenesis (OTC: CGCP.PK) is a leading medical device company that designs, develops and distributes laser-based surgical products and disposable fiber-optic accessories that treat diffuse coronary artery disease with a procedure called transmyocardial revascularization (TMR). Its products are marketed in the U.S. and around the world, and have been shown to reduce angina and improve the quality of life in patients. Cardiogenesis is located in Irvine, California. For more information on the company and its products, please visit http://www.cardiogenesis.com or the direct-to-patient website http://www.heartofnewlife.com or call 800.238.2205.
With the exception of historical information, the statements set forth above include forward-looking statements. Any forward-looking statements in this news release related to the company's sales, profitability, the adoption of its technology and products and FDA clearances are based on current expectations and beliefs and are subject to numerous risks and uncertainties, many of which are outside the company's control that could cause actual results to differ materially. Factors that could affect the accuracy of these forward-looking statements include, but are not limited to: any inability by the company to sustain profitable operations or obtain additional financing on favorable terms if and when needed; any failure to obtain required regulatory approvals; failure of the medical community to expand its acceptance of TMR or PMC procedures; possible adverse governmental rulings or regulations, including any FDA regulations or rulings; the company's ability to comply with international and domestic regulatory requirements; possible adverse Medicare or other third-party reimbursement policies or adverse changes in those policies; any inability by the company to ship product on a timely basis; the company's ability to manage its growth; adverse economic developments that could adversely affect the market for our products or our ability to raise needed financing; actions by our competitors; restrictions contained in our convertible debt obligations requiring the issuance of shares rather than repayment in cash; and the company's ability to protect its intellectual property. Other factors that could cause Cardiogenesis' actual results to differ materially are discussed in the "Risk Factors" section of the company's Annual Report on Form 10-KSB for the year ended December 31, 2006 and the company's other recent SEC filings. The company disclaims any obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
|SOURCE Cardiogenesis Corporation|
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