Medical Device Daily

After a few minor hurdles Cambridge Heart (Tewksbury, Massachusetts) is putting itself in a position to gain greater adoption for its lead product, the Microvolt T-Wave Alternans (MTWA) test, as well as gain a new indication for the application.

Cambridge Heart CEO, Ali Haghghi-Mood spoke with Medical Device Daily yesterday about the firm's MTWA test and an upcoming pilot trial that could secure some additional regulatory approvals for the product.

“Historically it's been since the existence of the electrocardiogram that if you have large visible changes in your T-wave [measurements] then that's not good news,“ Haghghi-Mood told Medical Device Daily. “You may experience an event – sudden cardiac arrest in the next 24 to 48 hours.“

The test has been approved by the FDA to help determine patients who are at high risk of developing sudden cardiac arrest.

He added, “what we do is actually look at changes that aren't visible to the naked eye. With what we have you're able to detect microvolt level changes of T-waves.“

By taking detailed ECG measurements during rest, exercise, and then rest again, the test can identify the presence of Microvolt T-Wave Alternans. The appearance of Microvolt T-Wave Alternans indicates the presence of a type of cellular metabolic activity that frequently leads to ventricular tachyarrhythmias.

In most situations, the test takes less than 30 minutes to perform. Following the placement of fourteen sensors - 7 Micro-V Alternans Sensors and 7 standard electrodes - the electrodes are connected to the digital ECG amplifier that leads back to the Microvolt T-Wave Alternans enabled system. At the beginning of the test, the patient is directed to begin walking on a treadmill to raise the heart rate. Patients who are unable to exercise can have their heart rates elevated pharmacologically to achieve the higher rate needed for a successful test.

The sub-maximal exercise portion of the test will be nearly eight to 10 minutes. Information will be collected for the Microvolt T-Wave Alternans Test while at rest, during exercise and at rest again. Upon test completion, the system analyzes the data and provides the Alternans Report Classification, which is an automatic interpretation of the test results. The test is classified as positive, negative or indeterminate.

But as much as the company touted the test, it wasn't getting the adoption rate that the firm would have liked. The company was once in a distribution deal with St. Jude Medical (St. Paul, Minnesota), but went with another distribution network that they felt would give it more market penetration.

“We signed an agreement in 2007 with St. Jude Medical, the agreement was an exclusive distribution through which the St. Jude sales team would sell our stand alone product,“ Haghghi-Mood said. “The idea was that this was a large sales force and they could sell our product. We had some initial success. But we expected a much higher rate of system placement.“

But there were some issues that forced Cambridge Heart to go in another direction with the MTWA test.

“The issue was not just a new product being in distribution,“ he said. “The problem was that this product had some integration issues.“

Feeling that the product would do much better as a companion to another device, the company formed a distribution partnership with Cardiac Science (Bothell, Washington). Cardiac Science has since been acquired by Opto Circuits (Bangalore, India) for $55 million but the agreement still stands according to the company (Medical Device Daily, Oct. 20, 2010).

“We terminated the [St. Jude] relationship and we started the module strategy,“ he said.

Under the partnership, Cardiac Science now includes the MTWA module on every new Q-Stress system.

The company also plans to further expand the indication for the MTWA test. According to the firm it is looking at seeking approval to help detect ischemia substrate in patients.

“We have obtained data from the field indicating that our technology is capable of indicating ischemia, which is otherwise undetected by other means such as stress tests and in some cases other modalities,“ he said. “So the data was good enough for us to launch a pilot trial that is ongoing as we speak.“

The pilot trial would evaluate up to 200 patients. So far there are already 120 patients involved.

He added, “the goal of the pilot trial is to verify the data we have obtained from users in the field. We believe that by the end of the year we would be able to present the results and analyze them. If the result is consistent in what we've seen then we can justify a full fledged study, a real study for labeling and reimbursement purposes.“

If Cambridge Heart were to garner FDA approval for this indication it would be huge for the company, Haghghi-Mood told MDD.

“What we can expect if the data holds is a new generation of stress systems,“ he said. “It's non invasive and cost effective, which is in line with the goals of the healthcare system, which is saving money and saving lives.“

Omar Ford, 404-262-5546;