TMR Laser carries FDA approval.
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Press Release Summary:
Designed to be part of TMR PLUS(TM) platform, SolarGen 2100s provides medical industry with laser console for performing Transmyocardial Revascularization (TMR). System features flexible power requirements and instantaneous system start up.
Original Press Release:
CardioGenesis Announces FDA Approval of Advanced TMR Laser
New SolarGen 2100s - First of a Series of Products to Expand TMR Market
FOOTHILL RANCH, Calif., Dec. 28 -- CardioGenesis Corporation (BULLETIN BOARD: CGCP) , the market leader in surgical products and accessories used in angina-relieving Transmyocardial Revascularization (TMR) and Percutaneous Myocardial Channeling (PMC) procedures, today announced the FDA approval of the SolarGen 2100s, an advanced laser console for performing TMR.
Chairman and CEO, Michael J. Quinn explained that "the SolarGen 2100s is the first in a series of significant, advanced product offerings intended to expand the TMR market. In the past 12 months, working closely with leading cardiovascular practitioners, we have implemented a minimally invasive initiative that will dramatically change the way TMR is performed, and how it is viewed by patients and referring physicians. Our minimally invasive strategy is consistent with the overriding trend in cardiovascular care ... providing improved patient outcomes with reduced morbidity and risk."
The Company has been preparing for the launch of the advanced TMR products, which they are naming the TMR PLUS(TM) platform. This advanced SolarGen 2100s is an important component of the new and improved TMR platform, as it removes many of the obstacles to performing the procedure that are directly related to the existing TMR technology.
"The SolarGen 2100s represents a significant platform advancement in the application of TMR in the operating room," Mr. Quinn stated. "The substantially reduced size and footprint of the SolarGen console, the flexibility of the power requirements, and the instantaneous system start up - - are all important benefits of this advanced technology. It dramatically increases the advantages of our platform to the hospital and the practitioner in terms of clinical ease of use."
The TMR PLUS platform will include a full range of minimally invasive delivery systems designed to reduce the morbidity associated with standard open surgical techniques, while adding technological features to enhance the physician's ability to visualize and treat all targeted areas of the left ventricle. Mr. Quinn stated, "FDA approval of the SolarGen 2100s is an important step forward for our Company. We are excited to launch this first component of our advanced TMR PLUS platform, which we expect to be followed shortly by the approval of the first of our minimally invasive delivery systems. We expect this advanced TMR console to help increase the utilization rates at TMR centers around the country, and provides us with the opportunity to significantly grow capital revenue for the first time since the initial approval of TMR."
Quinn emphasized that in 2005 the company is asserting itself as an innovative cardiovascular company providing tools for improved patient outcomes. The Company is preparing for the launch of its advanced TMR PLUS platform, as well as the CelleratOR system for point of care preparation of platelet rich plasma. He added, "We will continue to add to our market basket of innovative products, focusing on devices and therapies designed to treat advanced cardiovascular disease. 2005 is our opportunity to achieve significant revenue growth from these new products, and those we expect to add in the near future." Additionally, the Company recently launched a direct to physician and direct to patient web site (www.heartofnewlife.com) regarding TMR to help accelerate the awareness of TMR.
The company intends to highlight the advanced SolarGen 2100s TMR console, along with its minimally invasive TMR delivery systems that are currently in the regulatory process, and the CelleratOR system for point of care preparation of autologous platelet rich plasma at an educational symposium in conjunction with the STS meeting in January.
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.
For more information on the Company and its products, please visit the CardioGenesis company web site at www.cardiogenesis.com. or the patient and physician website at www.heartofnewlife.com. heartofnewlife.com is a resource for patients and physicians which provides medical information on TMR
For further information, please contact: Michael J. Quinn, Chairman and CEO, +1-714-649-5050, or Richard Lanigan, Senior VP, Marketing, +1-714-649-5024, both of CardioGenesis Corporation.
Web site: www.cardiogenesis.com/
