All 4 initial patients were successfully implanted with the Micra transcatheter pacing system and there have been no major post-implant complications at 1 and 3 months, Medtronic unveiled during this week’s Cardiostim 2014 conference in Nice, France. Medtronic calls Micra the "world’s smallest cardiac pacemaker," comparing the implant to the size of a large vitamin.
"We are encouraged by these preliminary results and are hopeful that this less invasive procedure will provide similar outcomes for all patients in the trial," study presenter and Linz General Hospital cardiology head Dr. Clemens Steinwender said in prepared remarks.
The experimental Micra device is a fully lead-free implant delivered via catheter to the heart, where it is attached to the heart wall with small tines. Pacing impulses are delivered from an electrode on the end of the device. Conventional pacemakers provide therapy via leads threaded into the heart from a pulse generator inserted into a pocket in the chest wall.
Medtronic began in February to implant the 1st patients with the Micra pacemaker, which is an investigational device worldwide. The Medtronic Micra Transcatheter Pacing System Global Clinical Trial currently underway will enroll up to 780 patients at about 50 centers around the world.
The medtech titan is chasing arch-rival St. Jude Medical (NYSE:STJ) and its Nanostim device in the race to get a leadless pacemaker on the market. St. Jude, which in October 2013 acquired Nanostim in a deal worth about $189 million, touted its own debut U.S. implantation just weeks before Medtronic; Nanostim is already on the market in Europe under a CE Mark approval.
In reports released during the Heart Rhythm 2014 conference in May, St. Jude said that Nanostim continued to look promising at 1 year in a small feasibility study, but concerns about patient safety led the company to temporarily suspend enrollment in an overseas registry. Researchers reported 6 instances of perforation, including 2 patient deaths, out of more than 200 implants.
St. Jude suspended the study in April in response to the patient deaths, the company told MassDevice.com. St. Jude evaluated the reports and presented its findings to the trial’s steering committee, which unanimously agreed to resume enrollment.
Sorin touts SafeR pacing with new algorithm
Sorin Group (BIT:SRN) presented new results from its ANSWER study of the SafeR pacing system, reporting that the algorithm helps reduce unnecessary shocks and helping to reduce the risk of cardiac death and heart failure-related hospitalizations. .
Compared with standard dual chamber pacing, patients with SafeR therapy experienced reduced 1-year ventricular pacing (95.4% versus 4.8%), which was sustained to 3 years (93.6% versus 11.5%). The effect was seen in both patients with sinus node disease and those with atrio-ventricular block, according to a press release.
There was no significant different in the number of patients hospitalized for atrial fibrillation or heart failure, but researchers reported a 51% relative risk reduction of cardiac death or heart failure hospitalization.
The ANSWER study seeks to build on previous research that suggest that unnecessary right ventricular pacing may damage the heart and reduce its function. The SafeR algorithm, designed to reduce potentially harmful shocks, is already present in all Sorin pacemaker and implantable cardioverter defibrillators, the company said.
St. Jude’s quadripolar leads leapfrog the competition
The "provocative" study, as cardiologist Dr. John Mandrola called it, suggests that defibrillator patients may see an 18% survival benefit over 2 years with quadripolar leads versus bipolar leads. Researchers examined remote monitoring data from more than 17,800 patients with quadripolar leads and more than 5,000 with bipolar leads, reporting a 5.84% mortality rate in the quadripolar arm compared with a 7.14% rate in the bipolar arm.