FREMONT, Calif.--(BUSINESS WIRE)--Cardima, Inc., a medical device company focused on the diagnosis and treatment of atrial fibrillation (AF), has received Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) to re-enter the Japanese market with its family of guidewire-based, multi-electrode PATHFINDER® diagnostic mapping catheters. Cardima’s PATHFINDER catheters, which are designed for accessing and mapping the vasculature of the heart wall to facilitate treatment of arrhythmias, will be imported into Japan through an exclusive distribution agreement with medical device distributor Robert Reid Inc., an import license holder, and marketed through Japan Lifeline Co. Ltd., an exclusive distributor of Robert Reid Inc.
“We are delighted to resume sales of our PATHFINDER catheters in Japan through Japan Lifeline, a well-established cardiac device distributor with an extensive marketing network within the electrophysiology and interventional cardiology communities. We thank Robert Reid for partnering with us and managing the Shonin process,” said Robert Cheney, Cardima’s CEO. “We increased our PATHFINDER inventory in anticipation of this approval and have already begun shipping products to Japan. PATHFINDER sales in Japan have the potential to provide Cardima with large revenue generation opportunities.”
Mr. Hideo Shitoto, President of Robert Reid Inc., stated, “The PATHFINDER’s low profile, small size, flexibility and multi-electrode design allow for entry into the most difficult and remote regions of the coronary vasculature. We believe these competitive features will be well received by the Japanese medical community. We look forward to reintroducing this product line in Japan and we hope to expand our relationship with Cardima to include additional products in the future.”
The PATHFINDER catheter is also approved for marketing in the U.S., Europe, Canada and Thailand.
About Cardima’s PATHFINDER
The Cardima PATHFINDER and PATHFINDER mini microcatheters are designed to map the inside vasculature of the heart wall, facilitating access to arrhythmia-causing tissue through the venous system. Among its attributes, the PATHFINDER provides for excellent tissue contact, optimal flexibility and handling facilitated by its tapered core wire and hydrophilic coating, excellent near field signals achieved with small electrodes, and an atraumatic platinum tip coil for added patient safety during placement. The Company also believes that the smaller catheter sizes offer marketing opportunities for proportionally smaller sized vascular systems.
The PATHFINDER allows for an intravascular approach to ventricular tachycardia ablation. The Company believes that the PATHFINDER’s ability to be positioned in close proximity to the arrhythmia-causing tissue will facilitate the creation of small, focused lesions – an approach that could be more effective than standard endocardial ablation procedures, with reduced destruction of surrounding healthy tissue, thus maximizing and optimizing the normal function of the heart after the procedure.
About Robert Reid Inc. and Japan Lifeline Co. Ltd.
Robert Reid Inc. is a privately held Japanese corporation headquartered in Tokyo. Its primary business is the manufacture and distribution of medical equipment and surgical implants. Robert Reid Inc. imports and distributes a diverse range of surgical products from the United States and Europe. The company also designs and manufactures its own original orthopedic surgical products. Robert Reid’s exclusive distributor Japan Lifeline’s principal activity is to wholesale medical devices for treatment of heart diseases, such as artificial internal organs, including implantable cardiac pacemakers, cardiac valves, blood vessels and disposable catheters, mostly imported from the United States and other European countries.
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. The Surgical Ablation Probe is intended for ablation of cardiac tissue using radio frequency (RF) energy during cardiac surgery. 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.
This press release may contain forward-looking statements, including but not limited to the large revenue generating opportunities in Japan from the sale of PATHFINDER catheters. These statements are subject to risks and uncertainties. Investors are referred to the full discussion of risks and uncertainties associated with forward-looking statements as contained in our reports to the Securities and Exchange Commission, including our Forms 10-K and 10-Q. The Company assumes no obligation to update the forward-looking information.
Richard Gaston, M.D.
Lippert/Heilshorn & Associates
Jody Cain (firstname.lastname@example.org)