Cardima 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. The Pathfinder catheter is also approved for marketing in the US, Europe, Canada and Thailand.

The company has claimed that 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 a distribution agreement with medical device distributor Robert Reid, an import license holder and marketed through Japan Lifeline.

Robert Cheney, CEO of Cardima, said: “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 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.”

Hideo Shitoto, president of Robert Reid, said: “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.”