St. Jude Medical announced the first U.S. implant of the leadless cardiac pacemaker as part of its LEADLESS II pivotal trial. The implant of the world’s first retrievable, non-surgical pacemaker took place at Mount Sinai Hospital in New York City.
The trial was undertaken to evaluate the effectiveness of the company’s Nanostim leadless pacemaker in addressing the heart rhythm issues among patients in the U.S. St. Jude will present the trial results for obtaining the U.S. Food and Drug Administration (FDA) approval.
St. Jude’s shares moved up 1.3% in the trading session following the announcement of the news. The stock is up around 3% since the news release.
Currently, Nanostim is available in select European countries but is still not commercially available in the U.S.
The Nanostim leadless pacemaker is the first miniaturized device that eliminates the need for leads. This novel feature makes the pacemaker, less invasive, allowing lesser complicated procedures for physicians as well as for patients around the globe.
The Nanostim leadless pacemaker can be directly placed in the heart without the visible surgical pocket, scar and insulated wires known as leads-primary characteristics of traditional pacemakers. The device provides physicians the same pacing therapy through a less-invasive approach, thus doing away with the need for more extensive surgery. The new offering from St. Jude Medical can be fully retrieved, which makes it flexible for repositioning through the implant procedure and simultaneously ready for retrieval as and when necessary.
Additionally, the small size and the lack of a surgical pocket combined with lead exclusion in the Nanostim leadless pacemaker is believed to increase patient comfort and reduce occurrences of infection. Moreover, with this revolutionary pacemaker allowing an unrestricted, active lifestyle post the implant, quality of a patient’s life will be largely unhampered through the use of this pacemaker.
Like other pacemakers and implantable cardioverter defibrillators (ICDs) belonging to the company, Nanostim leadless pacemaker is also supported by the St. Jude Medical MerlinProgrammer, which is often used to interrogate and program such devices.
St. Jude strongly believes that the introduction of this non-surgical pacemaker will be a great boon for cardiovascular medicine. The value-added features of the pacemaker can potentially help it emerge as a game-changing technology in the field of cardiac rhythm management.
The much-anticipated U.S. FDA approval, once achieved, will help St. Jude gain access to one of the largest healthcare markets in the world.
Currently, St. Jude carries a Zacks Rank #3 (Hold).
Investors interested in the medical products industry can look at better-ranked stocks like NuVasive, Inc. (NUVA - Free Report) , Baxter International Inc. (BAX - Free Report) and Covidien plc . While NUVA carries a Zacks Rank #1 (Strong Buy), COV and BAX hold a Zacks Rank #2 (Buy).