Cardima, a medical device company, has received regulatory approval from the Japanese Ministry of Health, Labor and Welfare for its guidewire-based, multi-electrode diagnostic mapping catheter, Pathfinder.
The approval will allow the product to re-enter the Japanese market through an exclusive distribution agreement with medical device distributor Robert Reid. The product will be marketed via Japan Lifeline, a distributor of Robert Reid, said the company.
According to the Fremont, Calif.-based company, the Pathfinder catheter provides an intravascular approach to ventricular tachycardia ablation and provides access to arrhythmia-causing tissue through the venous system.
According to Cardima, the Pathfinder catheter has also been approved for distribution in the U.S., Europe, Canada and Thailand.