World’s First Leadless Pacemaker is Now St.Jude’s

St. Jude Medical, Inc. has completed the acquisition of miniaturized, leadless pacemaker developer, Nanostim, Inc. The acquisition, which could eventually cost just under $200M adds the world’s first and only leadless pacemaker to the St. Jude portfolio.

Background

Cardiac pacemakers are used to treat bradycardia, monitoring the heart and providing electrical stimulation when the heart beats too slowly for each patient’s specific physiological requirements.

The Nanostim™ leadless pacemaker is uniquely designed for direct implantation 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 leads that have historically been recognized as the most vulnerable component of pacing systems.

This transaction results from St. Jude Medical’s exercise of its exclusive option to acquire Nanaostim, under agreements entered into over two years ago. St. Jude Medical paid $123.5 million to Nanostim shareholders at the closing of the transaction and the merger agreement provides for additional cash payments of up to $65 million, contingent upon both the achievement and timing of certain revenue-based milestones.

The Nanostim leadless pacemaker recently received CE Mark approval and will be available soon in select European markets. It also recently received U.S. 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.

Physician comments

“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,” said Dr. Johannes Sperzel of the Kerckhoff Klinik in Bad Nauheim, Germany. “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.”

Company comments

for St.Jude Medical, Inc.

“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 resynchronization therapy pacing,” said Eric S. Fain , M.D., president of the St. Jude Medical Implantable Electronic Systems Division. “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.”

for Nanostim, Inc.

Chief Executive Officer 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 commercialization initiatives and expand this technology into new and existing markets.”

Source: St.Jude Medical, Inc., Business Wire