Healthcare Industry News: Cardima
News Release - January 22, 2008
Cardima Announces Strategic Marketing Agreement With On-X Life Technologies Inc. for US Surgical Atrial Fibrillation (AF) Market
On-X to Market Cardima Surgical Ablation System to US Cardiothoracic Surgeons Under Exclusive AgreementFREMONT, CA--(Healthcare Sales & Marketing Network)--Jan 22, 2008 -- Cardima, Inc. (OTC BB:CADM.OB ) has announced a new strategic marketing relationship with On-X Life Technologies Inc. ("On-X") of Austin, Texas. Cardima has appointed On-X the exclusive US distributor for the Cardima Surgical Ablation System. On-X will market this system to cardiothoracic surgeons nationwide for closed-chest ablation procedures. The system can also be used in open chest, concomitant cases.
The Cardima Surgical Ablation System is comprised of Cardima's Surgical Ablation Probe and the INTELLITEMP® Energy Management Device. In a closed-chest procedure, the surgeon inserts the Surgical Ablation Probe into the patient's chest using only a right-sided port approach for access. This is a fast-paced operating room procedure that is performed off-pump on the beating heart. The pulmonary veins are encircled on the epicardial (outer) surface of the heart. The device is stabilized to the surface and radio frequency energy is applied through the electrode banks creating within a relatively short time, a long, continuous lesion surrounding the pulmonary veins. Additional lesions are created for optimal patient results.
Robert Cheney, CEO of Cardima, said that Cardima's alliance with On-X constitutes the official commercial launch of the Surgical Probe. "On-X has developed a prominent presence within the thoracic surgical community and has built tremendous trust with physicians. It is a strong endorsement of the Cardima surgical products that On-X has agreed to introduce our products to their extensive physician customer base."
The surgical probes, released under Cardima's existing FDA 510(k) clearance for the Surgical Ablation System, is "an important and exciting next step in Cardima's ability to address the needs of cardiac surgeons requiring cardiac tissue ablation procedures that are performed quickly, safely and meet the demanding requirements of key opinion leaders," said Cheney.
Commenting on the new strategic marketing relationship with Cardima, On-X CEO Clyde Baker said, "Our sales force is very excited to be able to offer physicians the Cardima Surgical Ablation System. We believe this system offers significant advantages in terms of safety, effectiveness and ease of use in a closed-chest setting that will soon make it the gold standard for this procedure among cardiothoracic surgeons."
Baker further notes that, "The Cardima System provides significant synergistic selling opportunities to cardiothoracic surgeons to whom we presently sell the On-X Prosthetic Heart Valve."
More about On-X
On-X Life Technologies manufactures and distributes highly advanced mechanical heart valves. The On-X heart valve is the result of a breakthrough in medical grade carbon technology: On-X® Pure Pyrolytic Carbon. In addition to providing a more thrombo-resistent surface, the comparatively high strength of pure On-X carbon enabled On-X to make significant valve design changes that resulted in a prosthetic that treats blood more like a natural valve. It is well documented that the On-X valve does not produce the turbulence and blood damage commonly produced by other mechanical heart valve prostheses and therefore significantly reduces the potential for life-threatening blood clots.
First implanted in 1996, recent clinical evidence suggests that patients implanted with the On-X heart valve may be able to forego or reduce the dosages of anticoagulation therapy traditionally required by mechanical heart valve recipients. This data has led the US FDA to approve an IDE for the PROACT (Prospective Randomized On-X Anticoagulation Clinical Trial), which is being conducted in 40 hospitals in the United States. The trial includes one test group of patients being maintained without the use of Warfarin.
More than 60,000 On-X valves have been implanted since 1996.
More information is located at www.onxvalves.com.
About Cardima
Cardima, Inc. has developed the PATHFINDER® and REVELATION® Series of diagnostic catheters, the INTELLITEMP® Energy Management Device, and the Surgical Ablation System (SAS). All of these devices are CE marked and received U.S. FDA 510(k) clearance. The REVELATION® Series of ablation catheters with the INTELLITEMP® EP Energy Management Device was developed and marketed for the treatment of atrial fibrillation (AF) after receiving CE mark approval in Europe; it is not currently available in the U.S.
For more information, please visit the Company's website at 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 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 third quarter ended September 30, 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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