CardioGenesis Corporation Announces Submission of PMA Supplement for Minimally Invasive Robotic Delivery System
Published: May 11, 2007
IRVINE, Calif., May 10 /PRNewswire-FirstCall/ -- Cardiogenesis Corporation , a leading developer of surgical products and accessories used in angina-relieving procedures, today announced 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.
Regarding this achievement, Richard P. Lanigan, President stated, "We are excited to have completed the Investigative Device Exemption (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 PEARL Delivery 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. During the review period, patients may be enrolled into the IDE study under continued access to receive TMR treatment using the PEARL Delivery System."
The Robotic PEARL 5.0 Delivery System is designed to be operated through a 5.0 mm port by Intuitive Surgical's 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.
Mr. Lanigan stated, "This advanced delivery system provides another significant technological advantage of our proprietary Holmium:YAG laser system compared to the CO2 TMR laser technology. Upon expected approval of the PEARL Delivery System, we will gain access to leading cardiothoracic programs worldwide that are implementing robotic technology. It will also provide Robotic TMR programs an innovative solution to advance the trend toward minimally invasive cardiac surgery."
About Cardiogenesis Corporation
Cardiogenesis is a medical device company specializing in the treatment of cardiovascular disease and is a leader in devices that stimulate cardiac angiogenesis. The Company's market leading Holmium:YAG laser system and disposable fiber-optic accessories are used to perform a FDA-cleared surgical procedure known as Transmyocardial Revascularization (TMR) to treat patients suffering from angina. Surgical products and accessories for the Cardiogenesis TMR procedure, which are marketed in the U.S. and around the world, have been shown to reduce angina and improve the quality of life in patients with coronary artery disease. Surgical products and accessories for the Company's minimally invasive Percutaneous Myocardial Channeling (PMC) procedure are currently being marketed in Europe and other international markets.
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.Cardiogenesis Corporation
CONTACT: William R. Abbott, Senior Vice President and Chief FinancialOfficer of Cardiogenesis Corporation, +1-949-420-1800