St. Jude Medical Inc. revealed that it has initiated post-approval trial for the Nanostim leadless pacemaker in order to evaluate the Nanostim leadless pacing technology. In this LEADLESS Pacemaker Observational Study, St. Jude Medical will enroll about 1,000 patients in nearly 100 centers in Europe.
Nanostim pacemaker obtained CE Mark approval in 2013. After its approval, the pacemaker has been implanted in patients located in the U.K., Germany, Italy, Czech Republic, France, Spain, and the Netherlands.
The study aims to provide evidence about the safety profile of the Nanostim leadless pacemaker in patients subjected to ventricular single chamber pacing. It will also present long-term data about the leadless pacemaker and provide additional information about the long-term performance of the device.
What Is So Different About This Pacemaker?
The Nanostim leadless pacemaker measures less than 10% of the size of a conventional pacemaker and can be implanted directly into the heart by a non-surgical procedure (through femoral vein with a steerable catheter), unlike conventional pacemakers, which require a more invasive surgery.
The pacemaker can be placed without the visible surgical pocket, scar and insulated wires (known as leads) needed for conventional pacemakers. It can be fully retrieved so that it can be readily repositioned throughout the implant procedure.
The smaller size and absence of a surgical pocket and a lead make the pacemaker comfortable for patients, reducing several complications, including device pocket-related infection and lead failure. It allows patients to live uninhibited lifestyles due to the elimination of the visible lump and scar at a conventional pacemaker’s implant site, apart from the removal of patient activity restrictions that may prevent the dislodgement or damage to a conventional lead.
The device is supported by the St. Jude Medical Merlin Programmer, used to interrogate and program the company’s other pacemakers and implantable cardioverter defibrillators (ICDs). The device battery is anticipated to have an average lifespan of more than nine years at 100% pacing, or more than 13 years at 50% pacing.
Other Nanostim Clinical Trials
Last year, St. Jude Medical conducted LEADLESS study in order to evaluate patients with the Nanostim leadless pacemaker. Results from that study indicated overall performance of the device comparable to conventional pacemakers and found that total implant procedure times averaged 28 minutes.
The first U.S. implant in the LEADLESS II pivotal trial, aimed for U.S. Food and Drug Administration (FDA) approval of the device, took place only last month. The trial, conducted under an Investigational Device Exemption (IDE) from the FDA, will enroll roughly 670 patients at up to 60 centers globally with up to 50 sites in the U.S.
Currently, St. Jude Medical carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the medical products industry include Enzymotec Ltd. (ENZY - Free Report) , Stryker Corporation (SYK - Free Report) and Covidien plc . Enzymotec and Stryker Corporation carry a Zacks Rank #1 (Strong Buy), while Covidien holds a Zacks Rank #2 (Buy).