Healthcare Industry News: RF Generator
News Release - May 22, 2007
CARDIMA(R) Announces First Human Procedure Successfully Performed Using Standard Thorascopic Techniques With 20-Electrode Irrigated Surgical Ablation Probe
FREMONT, CA--(Healthcare Sales & Marketing Network)--May 22, 2007 -- Cardima, Inc. (OTC BB:CRDM.OB ), a leading medical device company focused on the treatment of atrial fibrillation (AF), announced today that the first patient has been successfully treated with its new Surgical Ablation System (SAS) using standard thorascopic techniques, by cardiac surgeons at Anaheim Memorial Hospital in Anaheim, California. The system includes a 20-electrode surgical probe with a stabilization sheath, and the INTELLITEMP® radio-frequency (RF) energy management system. The surgical probe with the stabilization sheath received 510(k) clearance in the U.S. from the Food and Drug Administration (FDA) in 2006.Doctor Li Poa, M.D., who has a long track record of having performed over 150 thorascopic ablation cases with various existing technologies, led the procedure involving a 71-year-old male patient with a long history of intermittent AF. Only two small incisions on the right side of the patient's chest were required for instrument access into the patient's chest. After the procedure, the patient was converted from AF to normal sinus rhythm, and is presently in stable, satisfactory condition.
The Cardima probe is inserted by the surgeon into the patient's chest while the heart is beating, using side-ports for access. Guided by pericardioscopy, the surgeon then makes a small incision in the pericardium of the heart. Thereafter the pulmonary veins are encircled from the outside of the heart by placement of the Cardima probe; an illuminated tip at the probe is used to aid visualization inside the patient's chest. The probe's ablation electrodes are then stabilized onto the beating heart by application of suction. Within a relatively short time, a long and continuous 'box' lesion surrounding the pulmonary veins is created, replicating part of the highly successful surgical MAZE procedure for reduction of AF symptoms.
The ablation procedure lasted less than an hour. Dr. Poa, who is also the Chief of Cardiovascular and Thoracic Surgery at Enloe Medical Center in Chico, California, commented, "The unique technology behind Cardima's Surgical Ablation System (SAS) proved to work exceptionally well in this endoscopically guided case. The device safely created visible lesions that were distinctly very clean compared with those created by existing products on the market, and promises good transmurality and depth of penetration from the irrigated suction technology that drives RF energy deeper into the tissue."
"We are pleased that Dr. Poa opted to be the first surgeon to use our probe in a thorascopic procedure," said Gabriel Vegh, Chief Executive Officer of Cardima. "I believe that this event, along with the successes we see with our REVELATION® T-Flex ablation system used by cardiac electro-physiologists in Europe, further validates our technology. In the coming months, we will be concentrating on offering the SAS to surgeons in the U.S. who are ready to perform stand-alone thorascopic cardiac surgery on patients benefiting from an MAZE-like operation. However, we are continuing to look towards partnering with an organization committed to be part of the growth of the AF market."
The Cardima SAS uses commercially available surgical RF Generators, and Cardima surgical probes with varying lengths of multi-electrode linear array micro-catheter technology and the INTELLITEMP®. This energy management device developed by Cardima allows the appropriate RF energy to be applied to any single, any multiple, or all electrodes on the probe, simultaneously.
About Cardima
Cardima, Inc. has developed the PATHFINDER® series of diagnostic catheters, the REVELATION® series ablation system and the Surgical Ablation System for the diagnosis and treatment of tachycardias. The REVELATION® series with the INTELLITEMP energy management system was developed for the treatment of atrial fibrillation (AF) originating in the pulmonary veins of the heart and received CE mark approval in Europe. The Surgical Ablation System (SAS) with an INTELLITEMP received a 510(k) approval in the U.S. by the FDA.
The PATHFINDER and the REVELATION family of devices are intended for in use of in the Electro-physiology (EP) market and our Surgical Ablation System (SAS) for use in the surgical market. For more information please visit the Company's website at http://www.cardima.com.
Forward-Looking Statements
Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those expressed in or implied by such forward-looking statements. Potential risks and uncertainties include: the uncertainties associated with the prospects for FDA approval of any new devices; the prospect for any future clinical trials or regulatory activities; the risks associated with the Apix loan facility's restrictive covenants, security interest, fee provisions and other terms and conditions; the risk that the Company will not be able to raise additional capital in the immediate term as needed to continue operations and the risk that we will be unable to secure a strategic transaction involving the Surgical Ablation System. Additional risks and uncertainties are set forth in the Company's Annual Report on Form 10-KSB for the year ended December 31, 2006, the Company's Quarterly Report on Form 10-QSB for the first quarter ended March 31, 2007, and in the Company's subsequent SEC filings. The Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events or changes in the Company's plans or expectations.
Source: Cardima
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