Health & Fitness
Health and Fitness
Health and Fitness
Mon, February 23, 2009 Cardima Completes Second Atrial Fibrillation Training Session in Thailand
FREMONT, Calif.--([ BUSINESS WIRE ])--Cardima, Inc. (OTCBB: CADM) is a medical device company focused on the treatment of atrial fibrillation (AF) and manufacturer of the Cardima Surgical Ablation System and the REVELATION® line of therapeutic electrophysiology (EP) catheters. Cardima has successfully completed its second phase of training for cardiothoracic surgeons in Thailand on the use of the Cardima Surgical Ablation System, a true closed chest procedure for the treatment of AF. Cardima's EP product lines and the Surgical Ablation System have received product registration approval in Thailand.
The three-day training session was performed under the direction of Dr. Li Poa, Chief of Cardiothoracic Surgery and Cardiac Surgery Program Director at Stamford Hospital in Stamford, Conn., and faculty member of Columbia University College of Physicians and Surgeons. Dr. Poa worked closely with Dr. Suchart Chaiyaroj, Chief of Cardiothoracic Surgery at Ramathibodi Hospital in Bangkok and a member of the Faculty of Medicine of Mahidol University, and his associate Dr. Khanat Kruthkul. Three patients were treated during this session, bringing the total number to seven patients treated using the Cardima Surgical Ablation System under the Thai training program.
"The second phase involved further training of the Thai surgeons and electrophysiologists on the minimally invasive procedure we have developed at Stamford Hospital," said Dr. Poa. "The Cardima system is capable of creating a fairly complete, complex lesion set for the minimally invasive surgical treatment of lone AF with the establishment of both pulmonary vein and antral isolation, ablation of the right-sided gangliae and posterior inferior vena cava, and a crossing closed-loop lesion of the coronary sinus isthmus.
"The Cardima system has been shown to reliably and reproducibly establish both entrance and exit conduction block in its pulmonary vein isolation series. This is a very important development for achieving effective long-term results. The Cardima system can create continuous transmural lesions without gaps, and can be easily manipulated to create all the necessary lesions for a full surgical procedure."
Dr. Poa continued, "The Thai physicians who observed the procedures and participated in the training were very impressed by the minimally invasive nature of the procedure, its ability to create complex and deep lesion sets, the speed at which it can be completed, the visualization available to surgeons and the fact that patients are discharged the following day. They are very supportive of our efforts to establish a strong AF treatment program, as well as an AF Center of Excellence in Thailand."
Dr. Suchart is leading the training initiative on behalf of Ramathibodi Hospital, along with the support of Professor Rajata Rajatanavin, Dean of the Faculty of Medicine; Professor Piyamitr Sritara M.D., Deputy Dean Faculty of Medicine, Mahidol University and Director of Ramathibodi Cardiovascular Metabolic Center; Professor Krisada Ratana-olarn, Head of Surgery and Dr. Kruthkul, as well as other members of the Cardiology Department.
"Learning this new minimally invasive procedure for the effective treatment of AF is an exciting development for our surgical team at Ramathibodi," said Dr. Suchart. "My surgical team and EP colleagues have been extremely impressed by the procedure developed by Dr. Poa. We believe this very minimally invasive procedure opens a tremendous new treatment option for patients. Many persistently ill AF patients, or patients who have failed EP procedures, can benefit greatly from this Cardima procedure. We look forward to completing the initial training later this year and launching our own Cardima treatment program soon."
Several institutions and individuals have provided significant support for the development of a Center of Excellence for the treatment of AF in Thailand. In particular, the cardiology faculty at Ramathibodi Hospital, which is associated with Mahidol University, Dr. Poa, Dr. Suchart Chaiyaroj, Dr. Kruthkul, the Thai Ministry of Health, MEDS Global Healthcare USA, the Thai Finance Ministry and DKSH Healthcare-Diethelm Ltd., as well as Cardima.
"It was very exciting for me to attend this training session and meet with senior Thai surgeons and faculty. Observing the successful cases and Dr. Poa's strong rapport with the Thai surgeons was gratifying for the entire Cardima team," said Robert Cheney, Chief Executive Officer of Cardima. "We had productive meetings with both the public and private institutions that can play a role in the development and promotion of the AF Center of Excellence. We look to build on these relationships as the program advances over the coming months."
Cardima also announced that Dr. Poa presented at the IMPACT Convention Center, Bangkok, Thailand, as part of the 40th Anniversary of Ramathibodi Hospital, Mahidol University Medical Hub Symposium on February 10, 2009. His presentation highlighted advanced surgical techniques, including a detailed discussion on his procedure for the minimally invasive treatment of AF using the Cardima System.
Dr. Poa noted, "Strokes associated with AF account for direct acute care costs amounting to about $18 billion per year in the U.S. alone. If chronic care costs directly related to AF were included, the number would jump to around $50 billion. It is significantly more cost-effective to intervene in this disorder than let it proceed untreated, which typically leads to further patient suffering and added costs."
About Cardima Surgical Ablation System
The Surgical Ablation System uses Cardima's patented technology for the ablation of cardiac tissue. The System incorporates a microcatheter-based surgical probe coupled with Cardima's INTELLITEMP®, a radiofrequency energy management device. The probe incorporates irrigation, suction and illumination, which aid in placement and lesion depth. The Cardima Surgical Ablation System is able to create deep, long, linear and transmural cardiac lesions without gaps. The small, flexible design offers sole port-hole access, potentially decreasing procedure time, patient hospital stay and discomfort.
About Atrial Fibrillation
Atrial fibrillation (AF) is the most common cardiac arrhythmia and a major concern for healthcare providers worldwide. AF symptoms typically include a rapid and irregular heartbeat, palpitations, discomfort and dizziness. During AF irregular, disorganized and quivering spasms of atrial tissue results in the heart's failure to pump adequate amounts of blood throughout the body. AF is a leading cause of stroke, can cause congestive heart failure and adds to the morbidity of any underlying heart disease. Recent estimates are that more than 2.5 million people in the U.S. have atrial fibrillation, of which 1 million are symptomatic yet do not respond well to drug therapy. The cause of AF is unknown and there is no variation by geography or ethnicity. The incidence of AF increases with age. Furthermore, about 200,000 new cases are diagnosed each year in the U.S.
About Cardima
Cardima, Inc. has developed the PATHFINDER®, TRACER™ and REVELATION® Series of diagnostic catheters, the VUEPORT® and NAVIPORT® Series of guiding catheters, the INTELLITEMP® Energy Management Device and the Surgical Ablation System. All of these Cardima devices have received CE mark approval and U.S. Food and Drug Administration (FDA) 510(k) clearance. The REVELATION® Series of ablation catheters with the INTELLITEMP® EP Energy Management Device, developed for the treatment of atrial fibrillation (AF), has received CE mark approval and is marketed in Europe.
PATHFINDER®, TRACER™, VUEPORT®, NAVIPORT®, REVELATION® and INTELLITEMP® are registered trademarks of Cardima, Inc.
Forward-Looking Statements
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