St. Jude Medical and Nanostim have entered into a series of agreements in May 2011, pursuant to which, St. Jude Medical made an investment in, and obtained an exclusive option to acquire, Nanostim.

Under the terms of a merger agreement, St. Jude Medical paid $123.5m to Nanostim shareholders at the closing of the transaction.

In addition, the deal also provides for additional cash payments of up to $65m, subject to the achievement and timing of certain revenue-based milestones.

By acquiring Nanostim, St. Jude Medical has added the world’s first and only leadless pacemaker to its product portfolio.

Nanostim chief executive officer Drew Hoffman said that 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," Hoffman added.

Recently, the Nanostim leadless pacemaker obtained CE Mark approval and the device will be available in the European markets shortly.

The US Food and Drug Administration (FDA) has granted conditional approval to Nanostim for its investigational device exemption (IDE) application and pivotal clinical trial protocol to begin evaluating Nanostim leadless technology in the US.

When compared to the size of a conventional pacemaker, the Nanostim leadless pacemaker size is less than 10% and is designed to be implanted directly into the heart via a minimally invasive procedure.

The device improves patient comfort and can minimize complications, such as device pocket-related infection and lead failure.

Designed to be fully retrievable, the Nanostim leadless pacemaker can be readily repositioned during the implant procedure and later retrieved if necessary, such as at the time of normal battery replacement.