The device won CE Mark approval in the European Union shortly before St. Jude exercised the exclusive buyout option it acquired in a 2011 investment in Nanostim. The Nanostim pacemaker is designed to be placed inside the heart of a cardiac patient in a percutaneous, catheter-based procedure. The devices are leadless, and therefore aren’t connected to the heart muscle via wires, a modification over previous models that the company touts as major safety improvement.
St. Jude said the 1,000-patient Leadless pacemaker observational study is the largest leadless pacemaker investigation to date. The prospective, multi-center, post-market trial aims to establish the safety of the Nanostim device for ventricular single chamber pacing.
Post-approval implantations of the Nanostim device occurred in the UK, Germany, Italy, Czech Republic, France, Spain and the Netherlands, the company said.
"This large, European study was uniquely designed to help assess the health benefits associated with the Nanostim leadless pacemaker," principal investigator Dr. Johannes Sperzel of the Kerckhoff Klinik in Bad Nauheim, Germany, said in prepared remarks. "We look forward to adding to the already strong clinical evidence supporting the benefits to patients receiving this revolutionary technology."
"Nanostim pacemaker technology is one example of St. Jude Medical’s commitment to helping physicians improve health outcomes across the globe," added chief medical officer Dr. Mark Carlson. "Our European clinical trial aims to further demonstrate how the Nanostim pacemaker improves patient outcomes and implant procedure efficiency through its minimally-invasive design. We are delighted to see this groundbreaking technology enable physicians to improve the lives of patients worldwide."
St. Jude also said the 1st implantation in its 670-patient U.S. pivotal trial was performed in February. The St. Paul, Minn.-based company acquired Nanostim after purchasing a stake in May 2011 that included an exclusive option to acquire Milpitas, Calif.-based Nanostim. Other backers included InterWest Partners, US Venture Partners, Emergent Medical Partners and Life Science Angels. Nanostim raised $10 million in 2012 in an equity and options deal.
STJ shares were up 1.3% to $67.25 apiece as of about 11:30 a.m. today.