Boston Scientific (NYSE:BSX) needs some extra time to complete its MultiSense CRM monitoring study, the company told the Federal Communications Commission in requesting an extended waiver to access a restricted radiofrequency band.
The MultiSense trial, launched in 2010, combines the multi-sensor Cognis model cardiac resynchronization therapy defibrillator with Boston Scientific’s Latitude patient management system, which wirelessly transmits data from the CRT-D to the patient’s physician.
Boston Scientific said at the time that it was working on plans to develop a system that provides early warning of worsening heart failure by monitoring patient physiology via a suite of sensors contained in the implanted device.
The study requires that patients already be implanted with the Cognis system prior to enrollment, resulting in "unanticipated delays," according to the FCC report.
Patients enrolled in the study received a modification to their existing pulse generators to download an investigational software called Sensor Research Device-1, according to the ClinicalTrials.gov page for the MultiSense trial. The software collects sensor data in aims of doing so without affecting the implant’s CRT-D therapy. No hardware changes are necessary.
"Boston Scientific states that it needs a waiver extension to continue to manufacture and market its Cognis device in order to complete its on-going clinical trial," according to the FCC report. "Boston Scientific explains that unanticipated delays in enrollment for this trial have caused it to continue longer than expected, and that the trial results to date could be undermined if Boston Scientific is unable to complete the trial."
The Cognis device requires use of the 90-100 kHz frequency band in order to communicate, and the MultiSense trial can’t go on without continued access, according to an FCC document.
Boston Scientific in 2006 originally requested a waiver from the rule restricting the 90-110 kHz band, telling the FCC it needed time to develop new CRM technology that could communicate on different frequencies. The FCC granted that waiver and has approved 4 additional modifications and extensions since then, according to the agency.
The last deal would have expired on Nov. 17, 2012, but the extended approval grants Boston Scientific until December 2013.
"In light of the health benefits provided by this device and the value of a successfully executed trial in enhancing patient care, and because the risk of harmful interference to other authorized operations in the band is extremely small, we conclude that good cause exists, and the public interest would be served by, extending the existing waiver," the FCC concluded.
