St Jude Medical obtains CE Mark approval for leadless pacemaker

15 October 2013 (Last Updated October 15th, 2013 18:30)

US-based medical technology developer St Jude Medical has acquired Nanostim and its miniature leadless pacemaker following European approval of the device.

nanostim

US-based medical technology developer St Jude Medical has acquired Nanostim and its miniature leadless pacemaker following European approval of the device.

The Nanostim pacemaker is implanted using a steerable catheter through the femoral vein in a minimally invasive procedure, eliminating the need to surgically create a room for the pacemaker and insulated wires.

It is a modification over existing models that the company stresses as a major safety improvement.

The Nanostim pacemaker is less than 10% of the size of typical pacemakers, has a nine-year 100% lifespan or more than 13 years at 50% pacing.

The Nanostim leadless pacemaker is designed to be fully retrievable for enabling quick repositioning of the device during the implant procedure.

In addition, the leadless pacemaker is expected to yield better patient outcomes and enhance quality of life for patients as it eliminates the visible lump and scar at a conventional pacemaker's implant site and removes patient activity restrictions that may prevent the dislodgement or damage to a conventional lead.

The device also recently received the US 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 US.

Earlier this year, the company demonstrated the initial results from the LEADLESS study, a prospective, single-arm, multicentre study evaluating patients with the Nanostim leadless pacemaker.

The mean procedure time was 28 minutes and the performance of the device was said to be comparable to that of a traditional pacemaker.

S. Jude Medical implantable electronic systems division president Dr Eric S Fain said: "The Nanostim leadless pacemaker represents one of the most important advances in the history of pacing technology, and builds on St. Jude Medical's strong history of pacing innovation, beginning with the first implantable pacemaker in 1958 through the introduction of quadripolar cardiac resynchronisation therapy pacing.

"We look forward to welcoming Nanostim employees to St Jude Medical and to continuing our legacy of transforming the treatment of cardiac rhythm disorders with pioneering technology."

The device is supported by the St Jude Medical Merlin programmer that is also used to interrogate and programme the company's other pacemakers and implantable cardioverter defibrillators (ICDs).

Kerckhoff Klinik in Bad Nauheim, Germany Dr Johannes Sperzel said for the past 40 years the therapeutic promise of leadless pacing has been discussed, but until now, no one has been able to overcome the technical challenges.

"This revolutionary technology offers my patients a safe, minimally-invasive option for pacemaker delivery that eliminates leads and surgical pockets. This is the future of cardiac pacing."

"This revolutionary technology offers my patients a safe, minimally-invasive option for pacemaker delivery that eliminates leads and surgical pockets. This is the future of cardiac pacing," Dr Sperzel added.

The acquisition closes a series of agreements made between St Jude and Nano­stim in May 2011.

St Jude Medical paid $123.5m to Nanostim shareholders and the agreement also provides for additional cash payments of up to $65m based on a number of milestones.

Nanostim CEO Drew Hoffman said Nanostim's focus on bringing innovative technologies to the market closely aligns with St. Jude Medical's commitment to developing leading products and treatment options for patients and physicians worldwide.

"We are pleased to have recently received CE Mark approval for the Nanostim leadless pacemaker. Nanostim looks forward to now working as part of St Jude Medical to further advance our commercialisation initiatives and expand this technology into new and existing markets," Hoffman added.

According to the company, more than four million people worldwide have an implanted pacemaker or other cardiac rhythm management device, and an additional 700,000 patients receive the devices each year.

According to GlobalData estimates, Pacemakers market in Europe was valued at $1.58bn in 2012 and is expected to grow at a CAGR of 3.2% to reach $1.97bn by 2019.


Image: The Nanostim leadless pacemaker. Photo: courtesy of Business Wire.