Edwards Lifesciences (Irvine, California) reported this month that it is discontinuing its Lifepath AAA endovascular graft program for treating abdominal aortic aneurysms in order to shift some of its developmental resources to other areas. The move follows the company's report to analysts in December that it was exploring alternatives for the Lifepath program. However, it said that "an extensive search," had failed to identify a "suitable external partner" to purchase the business.

The decision to shift to other priorities also resulted from the company's acquisition of Percutaneous Valve Technologies (PVT; Fort Lee, New Jersey), according to Barry Liden, Edwards' director of global communications. The purchase of PVT for $125 million and a potential for $30 million in milestone payments was closed in January. It offers a large opportunity to pursue the percutaneous heart valve therapy being developed by PVT and make it "a major focus" for Edwards, Liden told Cardiovascular Device Update. "That was a fairly major acquisition, and a lot of our resources will be going into further development of that and other heart valve technologies in development," he said. Overall, the company is expanding R&D work in the minimally invasive technologies sector, including the development of minimally invasive hemodynamic monitoring systems, he said.

Edwards has spent eight years and put "tens of millions" of dollars into the Lifepath AAA program, representing "a significant portion of our research and development," said Liden. The effort experienced a halt in European trials in 2000 which were then restarted in 2001. The product has been cleared for sale in Europe and Australia.

AAA programs by other companies also have experienced setbacks, but Liden emphasized that Edwards has not abandoned the program because of any defect in the Lifepath product or any problems of safety or efficacy. "We've got a good device and it's performing very well in its trials and [has shown] really good performance in Europe," he said. "The issue is more financial and [one of] timing." He noted the existence of AAA products from other companies and "at this stage in the game, we would be one of the later ones to [the U.S.] market." He said that the company's trial data thus far has demonstrated that the Lifepath AAA product has proven "on a par" with competitors' offerings "and in some areas has better performance but not enough to grab enough attention and market share to provide a good return."

Edwards said it expects to report a first-quarter charge of about $10 million related to termination of the Lifepath AAA business. About $3.5 million of this charge is required as follow-up of trial patients over a three- to five-year period, Liden said. He added that sale of the Lifepath AAA product is still possible. But such a buyer would have to say, "We want to pay you what you think it's worth."

The company was in the midst of U.S. trials intended to support FDA approval targeted for later this year, Liden said but halted enrollment in those studies in January. Edwards said it will follow and report on patients currently enrolled in these studies in accordance with defined protocols and FDA requirements. In Europe and other markets where the Lifepath AAA system is cleared for sale, product availability and on-site implant support will continue through June, the company said.

Stuart Foster, Edwards' corporate vice president, technology and discovery, said, "This is a difficult decision for us because, despite encouraging Lifepath AAA clinical results, we need to focus our resources on other initiatives where Edwards has significant market leadership opportunities. We appreciate the support from clinicians who have recommended the Lifepath AAA system to their patients and will honor their trust in Edwards by striving to provide the most seamless transition possible."

GMP rolls out wireless LifeSync monitoring

Wireless is everywhere, wireless phones attached to nearly every ear and wireless laptops becoming just as ubiquitous. But for healthcare, wireless systems are experiencing relative infancy. Now, GMP Wireless Medicine, a subsidiary business of GMP Companies (both Fort Lauderdale, Florida), has begun marketing its LifeSync Wireless ECG System, addressing the long-standing "tethering" problem in monitoring that negatively impacts both patients and nurses. And the probable success of LifeSync is likely to lead the way to other such wireless healthcare opportunities.

The LifeSync System is the first monitoring system that eliminates lead wires and trunk cables between patients and bedside, 12-lead or transport ECG monitors. Employing Bluetooth wireless technology licensed from Motorola (Schaumburg, Illinois), the system uses two-way radios that transmit and receive patient ECG and respiration data to monitors. The company's disposable LeadWear System replaces the traditional wire tethering between patient and monitor.

Matt Likens, executive vice president of operations for GMP Wireless, explains that the system is comprised of three key pieces: a radio that works as a monitor transceiver placed on an existing ECG box while a second radio is carried by the patient via an armband or in a pouch or pocket. The third piece is the disposable Leadwear that connects the electrodes on the patient's body to the patient-worn transceiver. The patient transceiver picks up "vital signs, ECG and respiration" from the electrodes and transmits this data digitally to the monitor transceiver, Likens told CDU, noting that a key advantage of the system is its ability to connect to the monitors of various companies.

The wireless connectivity works over a distance of 100 feet, allowing patients to move about in their rooms or walk up and down a hallway. For movement to other parts of the hospital for whatever purpose testing or surgical procedures, say the system can be transferred to a transport monitor, with the patient again wirelessly "synced" to it for easy movement, according to Likens.

Arthur Gasch, president of Medical Strategic Planning (Lincroft, New Jersey), who follows the patient monitoring sector for CDU, calls the LifeSync "a very interesting product one of the first products that has used Bluetooth in a patient monitoring setting." Because the system is compatible with existing monitors, the hospital does not have to purchase an entirely new telemetry system to use it. That is both a benefit and barrier, Gasch said. Because it is not a stand-alone system, market uptake may depend on the willingness of the monitoring firms to back it with their distribution efforts, he says.

The LifeSync System is offered at an up-front price of about $1,000, with the company receiving a continuing cash flow of $30 for each disposable Leadwear wiring system. But the system offers a variety of other advantages in addition to better patient comfort and mobility which outweigh these relatively small costs, Likens asserts. For instance, the disposable LifeSync Leadwear offers the potential for large reductions in the burden of maintenance. "There are a lot of costs associated with the materials to clean [standard] lead wires between patient uses," with ECG techs having to clean them on "a continuous basis," he says. And he reports frequent breakage of leads when run over by carts or simply "degradation over time."

He also points to the system's ability to decrease nosocomial infections. While standard hardwired leads are continuously cleaned, Likens cites studies indicating that almost all standard monitor tethering contains various microbes and bacteria, sometimes lethal, which can be carried from patient to patient. By contrast, "since you don't have to put leadwires on [with LifeSync], the chance for contamination goes away," he says. Still another benefit of the system is decreased effort required by nurses in dealing with cabled ECG tethering. Using standard cabling, he says "leadwire management" eats up valuable time and energy.