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St. Jude Medical Acquires Leadless Pacemaker Developer

Nanostim pacemaker and Euro coin

Nanostim pacemaker compared in size to Euro coin (St. Jude Medical Inc.)

St. Jude Medical, a medical device company in St. Paul, Minnesota, is acquiring Nanostim Inc., a developer of self-contained leadless heart pacemakers in Sunnyvale, California. Shareholders in the privately owned Nanostim can receive up to $188.5 million in upfront cash and milestone payments as a result of the purchase.

St. Jude Medical has a relationship with Nanostim going back to 2011 when the company agreed to help finance Nanostim and develop its pacemaker device, in return for an exclusive option to acquire the company. Under the merger agreement, St. Jude Medical is paying Nanostim shareholders $123.5 million initally, who will also be eligible for up to $65 million in future milestone payments based on revenue targets.

Pacemakers are implanted in patients with an irregular or slower than normal heart rate, a condition known as bradycardia. Conventional pacemakers have a pulse generator with battery and timing circuits that generate regular and normal paced electrical impuses. Those impulses travel through thin wires into the heart called leads, which can also sense the patient’s heart rhythm and transmit those data to the pacemaker’s circuitry that send a compensating electrical signal.

Pulse generators of conventional pacemakers are surgically implanted in a small pocket under the patient’s collarbone, with the leads running to the heart. The leads need time to set in the body that require the patient to keep the area around the pulse generator inactive for a few weeks, otherwise they can loosen or disconnect. Surgical implants also run a risk of infection around the site of the pulse generator.

The pacemaker made by Nanostim is a self-contained device with the battery, circuitry, and sensors needed for pulse generation sitting inside the heart, removing the need for wire leads. It is implanted with a catheter that sends the device through the femoral vein in the thigh into the heart with a minimally-invasive surgical procedure.

The Nanostim pacemaker is about one-tenth the size of a conventional pacemaker, and because it has no leads nor pocket to hold the device, says St. Jude Medical, is less likely to result in site infections or dislocation of leads that can occur with conventional pacemakers. It can also be repositioned or retrieved after initial implant, such as for battery replacement.

A clinical trial with 36 bradycardia patients in Europe reported earlier this year that the Nanostim pacemaker worked as well as conventional pacemakers. The device received a CE Mark indicating approval for marketing in Europe, and according to St. Jude Medical, received an Investigational Device Exemption from the Food and Drug Administration allowing the company to begin clinical trials of the device in the U.S.

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