Medical Device Daily

Cambridge Heart (Tewksbury, Massachusetts) has been trudging uphill with its Microvolt T-wave Alternans test for sudden cardiac death (SCD) since the device was approved 10 years ago. Despite the fact that SCD makes up half of all heart disease-related deaths, cardiologists have been slow to adopt the technology. In its continuing effort to promote the diagnostic, the company has submitted a 510(k) application for an OEM Module enabling the technology to be integrated with standard stress tests.

"We entered into an OEM agreement with Cardiac Science (Bothell, Washington) last June, at the same time, we developed a new strategy to make the product more accessible to physicians and patients through this OEM arrangement," Ali Haghighi-Mood, Cambridge Heart's president/CEO told Medical Device Daily. "It's challenging out there for healthcare providers to access this technology in a cost-effective manner. An OEM would provide that opportunity. And, the OEM agreement solved a whole series of other integration problems that a single-product company like ours might present, from technician training to capital equipment expense. An OEM module doesn't have those obstacles. It can be offered to an installed based with a stress system already in use."

Heart attacks usually occur as a result of a blockage in one or more coronary arteries whereas SCD is the result of abnormal heart rhythms called arrhythmias. Death comes in just minutes and there are few warning signs or symptoms. Cambridge Heart's Heartwave II System is designed to measure microvolt T-wave alternans (MTWA) to help predict a person's risk of SCD. The non-invasive test originally developed at Massachusetts Institute of Technology [Cambridge, Massachusetts] works like a stress test. Fourteen electrodes are put on a patient who walks moderately on a treadmill for about 30 minutes. The test analyzes for subtle variations in electrical activity.

Development of the module version of the test is the centerpiece of the company's new business model that involves partnering with leading stress test equipment manufacturers to broaden the distribution and use of MTWA technology.

"The module can work with any computerized EKG machine," Haghighi-Mood said. "It's the size of a modern cell phone. The job is to acquire data from our sensors. Rather than having the whole system with all of the stand-alone hardware, now we have something that is limited to a small piece of hardware and analysis software. The benefit is that it can be offered as an upgrade to existing stress systems."

Cambridge Heart will continue to sell the Heartwave II as a stand alone system since it has dual purpose as both a SCD test and as a standard stress test machine.

A meta-analysis was conducted by a group led by Stefan Hohnloser, MD, of the Division of Cardiology at JW Goethe University (Frankfurt, Germany), and assessed 13 MTWA clinical studies involving roughly 6,000 cardiac patients. The results demonstrated that MTWA testing is a consistently accurate predictor of SCD (MDD, March 13, 2009).

Cambridge Heart continues to pursue healthcare professional awareness programs to make the test more available to a larger number of physicians who are taking care of patients with elevated risk for SCD.

"There hasn't been much awareness of SCA," Haghighi-Mood said. "In fact, there are different numbers given about incidence of SCA ranging from 300,000 to 450,000 in the U.S. You know what the pink ribbon is for. But SCA causes more casualties than all cancers combined yet there is no ribbon. Hopefully awareness will go up as will the demand for our tests and adoption of our technology. With the completion of the development work and our FDA regulatory submission, we are one step closer to making our Microvolt T-wave Alternans technology available to more physicians and their patients."

Lynn Yoffee; 770-361-4769

lynn.yoffee@ahcmedia.com