A Medical Device Daily

Cambridge Heart (Tewksbury, Massachusetts) reported a strategy aimed at boosting the sales and use of its Microvolt T-Wave Alternans (MTWA) technology, which is designed to predict a patient's risk of sudden cardiac arrest (SCA). The strategy calls for the company to partner with manufacturers of cardiac stress testing equipment to develop an OEM MTWA Module that will be integrated into their systems, and marketed to a much larger number of cardiologists and internal medicine practitioners.

Historically, Cambridge Heart's marketing strategy was focused on providing MTWA testing to those patients at highest risk for SCA and who were likely candidates to receive implantable defibrillation devices (ICDs). Although MTWA testing has clearly been demonstrated to be useful in identifying those individuals who could benefit from ICD therapy, clinical experience and a growing body of data suggests that MTWA technology can and should be used to identify and manage the risk of SCA in a much broader population of cardiac patients, according to the company. Cambridge Heart estimates that there are about 10 to 12 million heart attack and heart failure patients in the U.S., who can benefit from annual MTWA testing.

"To date, we have introduced our technology primarily through heart rhythm specialists, but the broader group of at-risk cardiac patients, who routinely undergo cardiac evaluations including stress testing, are typically under the care of cardiologists and internal medicine physicians," said Ali Haghighi-Mood, Cambridge Heart's CEO. "Our goal is to get the MTWA test to the largest number of appropriate patients."

According to the company, the MTWA Module would allow an integrated stress and MTWA test, using Cambridge Heart's sensors, to be performed on a partners' stress testing platform via customized software and patient interface. The manufacturer would market the MTWA Module as an upgrade to their existing installed base of stress systems, and as an optional feature to new stress customers.

As the first step in the execution of this strategy, the company says it has signed a non-exclusive development and distribution agreement with a leading U.S. stress manufacturer to develop a MTWA Module. However, citing "competitive considerations," the company said it is not disclosing additional details about the MTWA Module or the manufacturer's platform until the Module development is completed and the product is ready for launch. Cambridge Heart expects this will occur in 9 to 15 months based on development and regulatory approval timelines.

"In addition to ongoing efforts to position our Heartwave II product line for a broader application through our direct sales team, our new partnership and MTWA Module strategy make our technology more readily accessible, economically attractive and logistically simpler to integrate into the practice of those physicians who are already providing cardiac stress or other non-invasive testing," Haghighi-Mood said. "We look forward to sharing the partnership details and rolling out the new MTWA product embodiment in the coming months."

In other agreements/contracts news, GE Healthcare (Milwaukee) reported, as part of its healthymagination initiative, a research collaboration with the Healthcare Association of New York State (HANYS) and Bassett Healthcare (Cooperstown, New York) that GE says will make hospitals safer for patients. GE's Global Research Center and its partners are developing technologies for use in hospitals to identify and mitigate patient safety risks, including the Smart Patient Room and the Patient-Safety Forecaster, a tool used to model effectiveness and savings associated with patient safety interventions. Testing of the Smart Patient Room technologies and the Patient-Safety Forecaster is expected to begin at Bassett Healthcare this fall.

Smart Patient Room technology will initially focus on three common patient safety risks: hand hygiene, patient falls and clinical rounds adherence. Solutions developed through the healthymagination patient safety collaboration will support hospitals' efforts to improve health outcomes, reduce preventable medical errors and lower costs, GE said.

"Reducing medical errors requires a new understanding of the patient's hospital experience and the development of innovative, discrete technologies that mitigate safety risks," said Deepak Pillai, MD, program manager, GE Healthcare. "This collaboration brings together the technologies and data necessary to help keep patients safe. The result will be a solution that helps caregivers avoid preventable events and enhance patient care."

The Smart Patient Room will include technologies such as optical sensors to track the movement of clinicians and equipment, capture time between events and remotely read bar codes. The system will use artificial intelligence and multiple sensing technologies to monitor, for example, not only when hand washings occur, but also when hand washings should have occurred. As the first-ever technology to do both, the system will help address this often over-looked element of patient safety, according to the company. Data collected will also be used to create reports that compare actual treatment with recommended clinical protocol. Healthcare providers can use this information to manage clinical workflow, identify areas for improvement in care delivery and help ensure patient safety, GE said.

"Smart, predictive technology can help make patients safer and help hospitals operate more efficiently," said William Streck, MD, president/CEO of Bassett Healthcare. "Patient safety is critical to overall health care quality and an urgent industry-wide need. Bassett Healthcare is proud to partner in developing and testing these new technologies aimed at keeping patients safer."