Cardima, Inc. (OTCBB: CADM), a medical device company focused on the treatment of Atrial Fibrillation (“AF”) and manufacturer of the Cardima’s Surgical Ablation System and the EP Revelation(R) line of therapeutic catheters, has received approval from the Food and Drug Administration, Ministry of Public Health, in Thailand, to market its three main lines of products, including the diagnostic products, the EP therapeutic REVELATION line of products and the Surgical Ablation System.
“The market approval for Thailand is a further step in expanding the commercial potential of Cardima’s products worldwide and is also another significant stride in achieving our ongoing regulatory strategy,” said Robert Cheney, CEO of Cardima. “Thailand is an excellent market for Cardima because of its advanced medical infrastructure and highly trained physicians. Cardima is working closely with Dr. Li Poa of Columbia University Medical School and MEDS Global Healthcare USA in conjunction with Mahidol University and the Thailand Ministry of Health to position Cardima’s products to play a key role in establishing Centers of Excellence in Thailand for the treatment of Atrial Fibrillation.”
Thailand has a leading position globally in the rapidly expanding “Tourist Medicine” market. Dr. Rome Jutabha, a member of the MEDS Global Healthcare USA Advisory Board, commented on the Cardima product approvals, “MEDS Global Healthcare is working closely with Mahidol University and the Thailand Ministry of Public Health to establish several Atrial Fibrillation Centers of Excellence in Thailand. Leading Thai medical centers now treat over 1 million ‘tourist’ patients every year. Thailand wants to leverage their success in this market by focusing on key disease sectors. Atrial Fibrillation represents a huge global market with millions of untreated patients. MEDS Global Healthcare has identified Atrial Fibrillation as a problem requiring treatment resources that cannot currently be provided at adequate levels or at a reasonable cost in most, if not all, developed countries.”
The establishment of Centers of Excellence in Thailand, using Cardima’s Minimally Invasive Surgical System and its other diagnostic and EP ablation therapeutic treatment catheters, will offer patients globally new treatment options with the highest level of care and safety, and at a more reasonable cost. Dr. Jutabha states, “We are very excited to be working with Cardima, Dr. Li Poa, and the physicians at Ramathibodi Hospital on this important initiative.” Dr. Jutabha is an Associate Professor of Medicine at the David Geffen School of Medicine at the University of California, Los Angeles. He is also a member of the internationally renowned CURE Hemostasis Research Group.
Training on the Cardima Surgical Ablation System is expected to commence shortly under the direction of Dr. Li Poa in conjunction with Dr. Suchart Chaiyaroj, Chief of Cardiothoracic Surgery, at Ramathibodi Hospital. This initiative to establish AF Centers of Excellence in Thailand was heavily supported by the cardiology faculty at Ramathibodi Hospital with the significant help of Dr. Khanat Kruthkul. Ramathibodi Hospital is a teaching hospital associated with Mahidol University which is one of the oldest medical schools in Thailand and a highly recognized center for medical training and research.
Dr. Li Poa commented: “We have had great results working with the Cardima minimally invasive Surgical Ablation System. I am excited to introduce this new treatment option to Thailand as part of the program developing AF Centers of Excellence working with MEDS Global Healthcare, Ramathibodi Hospital, leading Thai physicians and the Thai Ministry of Public Health. Atrial Fibrillation is a very large public health issue globally with millions of patients going untreated every year, frustrating both patients and physicians. Treatment, utilizing Cardima’s solutions, needs to be made available to patients. We hope that through the development of these Centers of Excellence in Thailand, patients globally will have one more option in accessing treatment. I have worked with many technologies and products to treat AF, but our first choice for training and patient treatment in Thailand will be Cardima’s.”
Dr. Poa is the Chief of Cardiothoracic Surgery and Cardiac Surgery Program Director at Stamford Hospital, Connecticut; a major teaching affiliate of the Columbia University College of Physicians and Surgeons where he is a faculty member. Dr. Poa specializes in endoscopic cardiac access and the surgical treatment of AF and other minimally invasive techniques.
About Cardima
Cardima, Inc. has developed the PATHFINDER(R), TRACER(R) and VUEPORT(R) Series of diagnostic catheters, the NAVIPORT(R) Series of guiding catheters, the REVELATION(R) Series of ablation catheters, the Surgical Ablation System with its series of ablation probes, and the INTELLITEMP(R) Energy Management Device Series for RF (radiofrequency) energy management. These devices are CE marked and/or received United States 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) with CE mark approval in Europe; it is not yet commercially approved in the United States.
Contact: Dr. Richard Gaston Cardima, Inc. (510) 354-0300 http://www.Cardima.com
SOURCE: Cardima, Inc.
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