Medical Device Daily Associate Managing Editor

Transoma Medical (St. Paul, Minnesota), a developer of implantable wireless diagnostic systems, reported what it called an “important milestone“ for the company with the first patient implants of its Sleuth ECG (electrocardiogram) monitoring system.

The procedures were performed by Jose Alberto Arrocha, MD, and Andrew Krahn, MD, at the Clinica Marbella (Panama City, Panama).

According to Brian Brockaway, CEO of Transoma, the first human implants represent Transoma's push into the clinical diagnostics market (via its Patient Management Device Division), which he said could be worth in excess of $100 million in five years. He told Medical Device Daily that the Sleuth is based on technology already being used in the company's sister division, Data Sciences International (also St. Paul), for monitoring and collecting physiological data in biomedical research.

“Now we're leveraging that technology platform to develop this line of products for monitoring patients with chronic cardiovascular disease to provide physicians with information that will help them make better therapeutic decisions to keep patients out of the hospital and reduce the cost of care as well.,“ Brockaway said. “We see this as a major contribution to the change in the way that patients with chronic cardiovascular disease are going to be cared for in the future.“

The Sleuth — a device about the size of a 50-cent coin — is implanted under the skin to continuously monitor the patient's heart. As it gathers the cardiac information it automatically and regularly forwards the data to a computer for physician review. The data is then triaged by certified cardiac technicians, with reports of relevant cardiac event data are forwarded to the physician.

“This [implant] procedure required only a short amount of time and was much simpler than implanting a pacemaker, said Arrocha, an associate investigator at the Instituto Conmemorativo Gorgas de Estudios de la Salud (also Panama City). “The Sleuth system is transmitting data as expected, and is operating very smoothly. As a physician, I look forward to having more detailed, timely data to diagnose conditions and prescribe the right therapy for individual patients. I also believe my patients will find this system easy to use.“

“Certain cardiac conditions that occur infrequently, including unexplained syncope [fainting] and arrhythmias, are particularly challenging to diagnose,“ said Krahn, director of the Arrhythmia Monitoring Unit, London Health Sciences Centre University Hospital (London, Ontario), who attended the Sleuth implants. “This remote monitoring system will be an important advancement in technology to monitor and improve the care of patients with chronic heart disease.“

Brockaway told MDD that medical device kingpin Medtronic (Minneapolis) has had a similar device, called the Reveal, available on the market for several years, but he pointed out several differences.

“The biggest advantage [to the Sleuth] over the Medtronic device is that this has some technology in it that allows the patient to be monitored with almost no compliance. All they have to do is come within two meters of a handheld device that relays the information to a service center on a daily basis.“

With the Medtronic device, he said, “the patient has to come into the clinic to be downloaded.“

Transoma's products include the software to condense the data these devices provide into meaningful information.

Brockaway reported that Transoma has raised $25 million in its first two rounds of private financing, with the most recent round being completed in October 2005 for $12.7 million. He said that the company would most likely go through at least one more private round of financing before looking for the proper exit strategy, which he hinted could be an initial public offering.

The company expects to have products available in the U.S. and Europe sometime next year.