A Medical Device Daily

Medtronic (Minneapolis) reported that it has received Japanese regulatory approval for the Reveal DX Insertable Cardiac Monitor (ICM). The device has been designated by the Japanese government as a high-priority medical device, and the company says it is the first insertable cardiac monitor to be introduced in Japan.

The Reveal DX ICM provides insight into syncope, unexplained fainting episodes. Syncope is difficult to diagnose as episodes are often too infrequent and unpredictable for detection with conventional monitoring techniques such as ECG Holter monitors or external loop recorders. These tests are limited to 24 hours and one month, respectively; combined with the constraints placed on the patient's daily life and the limited likelihood of an event occurring during the monitoring period, the testing may fail to determine the cause of the episodes, according to Medtronic.

Causes of syncope can be heart rhythm disturbances or abnormalities in the structure of the heart. Syncope can lead to serious injury or can be a precursor to sudden cardiac death. Roughly 1.5 million people worldwide suffer from unexplained syncope. In almost 10% of patients, syncope has a cardiac cause.

Inserted just under the skin of the chest area, Medtronic said the Reveal DX ICM is about the size of a memory stick and is capable of monitoring patients for up to three years, allowing for long-term, continuous cardiac monitoring. Records of arrhythmias are automatically recorded and saved, and patients may prompt the device to record any events at any time. If the patient experiences a syncopal episode, the information collected by the device may help the physician determine if the episode is attributable to an arrhythmia.

Since no similar device has been available in Japan, the Ministry of Health, Labor and Welfare designated the Reveal DX as "high priority" for approval in Japan. The device was subject to a fast-track evaluation by the Japanese government, and received regulatory approval this month.

Medtronic Japan will begin marketing the Reveal DX ICM once it has attained reimbursement approval for the device. The company will partner with Asahi Kasei for exclusive sales distribution rights for the device in Japan; Medtronic Japan will serve as the device's designated marketing authorization holder.

The Reveal DX ICM is commercially available in the U.S., Western Europe and Canada.

Repel-CV okayed in Canada

SyntheMed (Iselin, New Jersey), a developer of anti-adhesion, drug-delivery products and other surgical implants, said its Repel-CV bioresorbable adhesion barrier film for the reduction of adhesions following cardiac surgery has received approval from Health Canada for use in pediatric patients who undergo open-heart surgery.

Repel-CV will be marketed throughout Canada by Force3 Medicale (Montreal), a distributor of cardiac surgery products. Marc Sportsman, SyntheMed vice president of sales, said, "We are pleased to receive the Health Canada approval which allows us to further expand the international distribution of REPEL-CV."

Adhesions, or scar tissue, occur after virtually all open-heart surgical procedures, often resulting in the heart becoming attached to the sternum and other surrounding tissue surfaces. The presence of adhesions represents a prevalent and serious complication in secondary surgical procedures, increasing the length, cost and risk of the surgical procedure.

Repel-CV is a bioresorbable adhesion barrier film designed to be placed over the surface of the heart at the conclusion of an open-heart surgical procedure to reduce the extent and severity of adhesions (scar tissue) that form between the surface of the heart and opposing tissue surfaces following surgery. Repel-CV is designed to provide the therapeutic benefit and then degrade so that it is cleared from the body. The company said it is the first in a series of anti-adhesion products under development based on the company's proprietary polymer technology.

SyntheMed develops anti-adhesion systems, drug delivery products and other surgical implants. The company is focused on the advancement of product development programs based on its bioresorbable polymer technology.

Draximage to market Lymphoseek

Neoprobe (Dublin, Ohio), a developer of oncology and cardiovascular surgical and diagnostic products, reported executing a non-binding letter of intent with Draximage (Kirkland, Quebec), a division of Draxis Specialty Pharmaceuticals, for Draximage to exclusively distribute Lymphoseek in the European Union, Switzerland, Scandinavia, Turkey, Canada and India.

The companies said they hope to complete definitive agreements in the next 90 days. Under the terms of the arrangements, unradiolabeled Lymphoseek kits will be sold to hospitals through Draximage's marketing channels in the territory covered by the agreements but specific terms will not be disclosed until the agreements have been executed.

David Bupp, Neoprobe's president/CEO, said "The completion of the agreements coupled, with the announcement of preliminary results for the Phase III clinical evaluation of Lymphoseek, will be important upcoming milestone events for the company."

Lymphoseek is a radioactive tracing agent being developed for use with gamma detection devices in a surgical procedure known as Intraoperative Lymphatic Mapping.

The agent has completed a multi-center Phase II clinical study evaluating the efficacy and safety of Lymphoseek in patients with either melanoma or breast cancer. Neoprobe has reported that the final top-line data showed that Lymphoseek identified lymphatic tissue in 99% of treated patients.

The company has commenced patient enrollment in the first of two Phase III clinical studies to evaluate the safety and efficacy of Lymphoseek as a sentinel lymph node tracing agent.