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Early Trial Shows Wireless Pacemaker Safe, Effective

Nanostim pacemaker and Euro coin

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

24 March 2014. Researchers at Mount Sinai Hospital in New York found in an early-stage clinical trial, a smaller and lead-less heart pacemaker could be safely implanted and operate for at least three months without complications. The team led by Mount Sinai cardiologist Vivek Reddy — with colleagues in Netherlands, Germany, and Czech Republic, and the company Nanostim Inc. that developed the device — published its findings online today in the journal Circulation, published by American Heart Association (paid subscription required).

Nanostim, in Sunnyvale, California, sponsored the trial. The company was acquired by medical device manufacturer St. Jude Medical in October 2013 for $123.5 million in cash, plus up to $65 million in future milestone payments.

Pacemakers are implanted in patients with an irregular or slower than normal heart rate, and generate normal-paced electrical impulses through thin wires into the heart called leads, which also sense the patient’s heart rhythm to send a compensating electrical signal. These conventional pacemakers are surgically implanted under the patient’s collarbone, with the leads running to the heart. The leads, however, need time to set requiring the patient to keep the area around the pulse generator inactive for a few weeks, to prevent disconnecting. Surgical implants also run a risk of infection around the implant site.

The Nanostim device is about one-tenth the size of a conventional pacemaker and self-contained with a battery, circuitry, and sensors sitting inside the heart, removing the need for wire leads. It is designed for patients needing to stimulate one chamber of the heart, a condition affecting 20 to 30 percent of patients requiring pacemakers. The device is inserted with a minimally-invasive procedure using a catheter that sends the device through the femoral vein in the thigh into the heart. It can also be repositioned or retrieved after initial implant, such as for battery replacement.

Reddy and colleagues tested the safety of the implantation procedure and initial clinical performance of the Nanostim device in an early-stage clinical trial with 33 patients in the Netherlands and Czech Republic having a slow or irregular heartbeat. Two-thirds of the patients were male, with an average age of 77.

Nearly all — 32 of 33 — patients had their devices implanted without complication, although 5 patients required implanting more than one device during the procedure. One patient developed complications during the implantation and later died from a stroke. After 3 months, 31 of the original 33 patients reported the lead-less devices were operating properly, with their heart pacing either improved or stable.

A later-stage clinical trial of the Nanostim device, sponsored by St. Jude Medical, is currently recruiting 667 patients. Reddy is the study director, with Mount Sinai Hospital listed as one of the sites.

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