|Medtronic Receives FDA Approval For Advisa MRI Pacemaker System; Peregrine Reports Results from Phase 2 Trial of Bavituximab|
|By Staff and Wire Reports|
|Wednesday, 13 February 2013 18:45|
Showcasing its leadership position in pacing technologies, Medtronic, Inc. (NYSE: MDT) announced the U.S. FDA approval and U.S. launch of its Advisa DR MRI(TM) SureScan® pacing system. The Advisa MRI system is Medtronic's second-generation MR-Conditional pacemaker and is the first system to combine the most advanced pacing technology with proven MRI access.
MRI is the standard of care in soft tissue imaging, providing information not seen with X-ray, ultrasound or CT scans, and is critical for early detection, diagnosis and treatment. Advisa MRI was specifically tested and approved for use as labeled with MRI scanners in the U.S. Of the 156 patients scanned in the Advisa MRI Clinical Trial, none showed any MRI-related complications. The new system includes an Advisa MRI device and two CapSureFix MRI^(TM) SureScan® leads, which must be used together.
"Your physician can implant a pacemaker with advanced options that will allow for broad access to MRI scanning," said Dr. J. Rod Gimbel of Cardiology Associates of East Tennessee in Knoxville, Tenn. "MRI is just so very important and traditional pacemakers not FDA approved for MRI scanning often prevent the patient from having an MRI when they need it. With more than 85 percent of pacemaker patients being at least 65 years old and having multiple comorbidities for which MRI may be needed, it's key that physicians and patients have a pacing system that allows MRI imaging as a diagnostic procedure."
The first SureScan pacemaker system was introduced in Europe in 2008 and its use in the MRI environment is supported by clinical studies and extensive computer modeling, as well as real-world data. To date, more than 100,000 Medtronic SureScan devices have been sold worldwide; and, in the U.S., it is estimated that more than 10 percent of patients with SureScan pacing systems have received MRIs. These patients received Medtronic's first-generation Revo MRI® SureScan® pacing system, which was the only FDA approved (February 2011) MR-Conditional pacemaker in the U.S. before the Advisa MRI system.
Until the availability of Medtronic's SureScan pacing systems, patients with pacemakers in the U.S. have been contraindicated from receiving MRI scans because of potential interactions between the MRI and device function. According to published literature, up to 75 percent of patients worldwide with implanted cardiac devices are expected to need an MRI scan during the lifetime of their devices.
Peregrine Pharmaceuticals (NASDAQ: PPHM) announced results from its 70 patient open-label, randomized Phase II clinical trial of bavituximab used in combination with gemcitabine in patients with previously untreated, advanced Stage IV pancreatic cancer. The trial included the enrollment of patients with advanced metastatic disease including significant liver involvement and poor performance status associated with rapid disease progression.
Results showed that the combination of bavituximab and gemcitabine resulted in more than a doubling of overall response rates (ORR) and an improvement in overall survival (OS) when compared with gemcitabine alone (control arm). In the trial, patients treated with a combination of bavituximab and gemcitabine had a 28% tumor response rate as compared to 13% in the control arm. Median OS, the primary endpoint of the trial, was 5.6 months for the bavituximab plus gemcitabine arm and 5.2 months for the control arm (hazard ratio = 0.75).
The pancreatic cancer trial is a randomized, open-label Phase II trial evaluating bavituximab with gemcitabine versus gemcitabine alone in up to 70 patients with previously untreated stage IV pancreatic cancer. The trial allowed the enrollment of patients 18 and older without any age limit, distant organ involvement and ECOG performance status of 0-2. In this trial, bavituximab was generally safe and well tolerated in combination with gemcitabine with similar adverse events occurring in both arms.
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