A blog about what is new (and old) in the world of active implantable medical devices

Category Archives: Nanostim

St. Jude Implants First US Patient with its Nanostim Leadless Cardiac Pacemaker

Posted on by Posted in Cardiac Pacing, Nanostim, St. Jude Medical

IMAGE_Nanostim_Product_Shot[1]

St. Jude today announced the first U.S. implant in the company’s LEADLESS II pivotal trial designed to evaluate the Nanostim™ leadless pacemaker for FDA approval. The world’s first retrievable, non-surgical pacemaker was implanted at The Mount Sinai Hospital in New York City by Dr. Vivek Reddy.  The LEADLESS II pivotal trial is a prospective, non-randomized, multi-center, international clinical research trial designed to evaluate the safety and effectiveness of the Nanostim leadless pacemaker in patients indicated for the device. It is being conducted under an Investigational Device Exemption (IDE) from the FDA, and will enroll approximately 670 patients at 50 centers in the U.S., Canada and Europe.

According to the press release:

The Nanostim leadless pacemaker is designed to be placed directly in the heart without the visible surgical pocket, scar and insulated wires (called leads) required for conventional pacemakers. Implanted via the femoral vein with a steerable catheter, the device offers physicians the same pacing therapy through a less-invasive approach as compared to traditional pacemaker procedures that require more extensive surgery. The device is designed to be fully retrievable, so that it can be readily repositioned throughout the implant procedure and later retrieved if necessary.

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St. Jude Acquires Nanostim, Announces CE Mark of World’s First Leadless Pacemaker

Posted on by Posted in AIMD Business, Bradycardia, Cardiac Pacing, Nanostim, St. Jude Medical

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St. Jude Medical today announced the completion of its acquisition of Nanostim, Inc., a privately-owned developer of miniaturized, leadless pacemakers. The acquisition adds the world’s first and only leadless pacemaker to the St. Jude Medical product portfolio.

httpv://youtu.be/P6PLiyzatOo

According to the press release:

Unlike conventional pacemakers that require a more invasive surgery, the Nanostim™ leadless pacemaker is designed to be implanted directly into the heart via a minimally invasive procedure. The device is delivered using a steerable catheter through the femoral vein, eliminating the need to surgically create a pocket for the pacemaker and insulated wires (called leads) that have historically been recognized as the most vulnerable component of pacing systems. The Nanostim leadless pacemaker recently received CE Mark approval and will be available soon in select European markets. It also recently received U.S. Food and Drug Administration (FDA) conditional approval for its Investigational Device Exemption (IDE) application and pivotal clinical trial protocol to begin evaluating Nanostim leadless technology in the U.S.

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Nanostim’s Leadless Pacemaker

Posted on by Posted in BetaBatt, Bradycardia, Cardiac Pacing, EBR Systems, Medtronic, Nanostim, Nuclear Batteries

Nanostim's leadless pacemakerNanostim is an early-stage AIMD company in Milpitas, CA that is developing a pacemaker that can be implanted inside the heart through a catheter.  The tiny device is attached directly to the heart, eliminating the need for leads.

In May 2011 Nanostim announced that St. Jude Medical had made a substantial investment in the company.

The company is operating in stealth mode, but some details about the leadless pacemaker have emerged from Nanostim’s patents and patent applications.  An interesting detail is about the possible use of a betavoltaic power source: Continue reading→

BetaBatt’s Modern Betavoltaic Cells to Power Active Implantable Devices

Posted on by Posted in BetaBatt, Nanostim, News, Nuclear Batteries
Porous-silicon diode membrane being developed by BetaBatt for an implantable betavoltaic cell
Image Credit: University of Rochester

Nuclear energy cells that converted the impact of the β-particles on a p-n junction were developed in the 1970s.  One example was CCC’s atomic pacemaker, which was powered by a promethium-147  McDonell-Douglas Betacel 400.

Lately, BetaBatt Inc. of Houston, TX licensed beta-voltaic technology developed  at the University of Rochester to develop an implantable power source under the trade name DEC™ Cell, in which a silicon wafer captures electrons emitted by a radioactive gas such as tritium. The wafer is etched in a three-dimensional surface to capture more electrons.  The battery is sealed in a hermetic package  which  entirely  contains  the  low-energy  particles emitted by tritium, rendering the battery safe for long-term human  implant  from  a radiological-health standpoint.  Tri­tium has a half-life  of 12.3 years so that the technology  is more than adequate to meet the requirements of many implantable devices. Continue reading→