St. Jude said a subset of data from the Leadless II trial showed that its Nanostim device was was successfully retrieved in 14 patients up to 3.2 years after implantation, with no serious adverse events.
“We’ve now shown that for patients requiring device upgrades or new leadless pacing options, late retrievability – even up to 3 years – is possible with the Nanostim leadless pacemaker,” lead investigator Dr. Vivek Reddy, of New York City’s Mount Sinai Hospital, said in prepared remarks.
Leadless II also compared a 718-patient Nanostim-implanted group with a cohort of 10,521 patients implanted with traditional transvenous pacers, using data from Truven MarketScan tracking of healthcare claims and Medicare supplemental insurance encounters.
Acute complications occurred in 5.8% of the Nanostim group, compared with 12.7% of patients in the traditional pacer arm. Mid-term complications in the 1st 2 years after implantation were 0.6% for the Nanostim arm and 5.4% for the TVP arm, the Leadless II data showed.
“Real-world claims data indicate higher-than-previously-reported rates of TVP complications with clear advantages for LCPs among infectious and lead-related events. LCPs and TVPs had similar rates of dislodgement and pericardial effusion,” according to the study.
“We are extremely pleased to see these three presentations provide additional insight into the potential benefits associated with the Nanostim leadless pacemaker,” said St. Jude’s chief medical officer, Dr. Mark Carlson. “The Nanostim leadless pacemaker has been available to patients in Europe since 2013 and we continue to work with the FDA to bring the Nanostim leadless pacemaker to the U.S. market to ensure broad patient access to this important therapy.”
St. Jude’s Twin Cities rival Medtronic touted an industry 1st at HRS 2016 – the ability of its Micra leadless pacer to measure patients’ movement using an accelerometer and calculate an appropriate pacing rate. A 20-patient study of stress test data at 3 and 6 months showed that “appropriate rate-responsive pacing is achievable with an entirely intra-cardiac accelerometer-based pacing system,” Medtronic said.
“Many patients with bradycardia require rate-responsive pacing so that their heart rates increase during exercise,” Dr. Razali Omar, of Malaysia’s National Heart Institute, said in prepared remarks. “Conventional pacemakers use various sensors outside the heart to detect patient activity, but even these sensors can have difficulty detecting moderate physical activity. As data presented today show, the Micra accurately responds to patients’ activity levels by adjusting therapy when needed using a sensor within the heart.”
Both Nanostim and Micra have won CE Mark approval in the European Union, but only Micra has won a nod from the FDA in the U.S. The 3rd player in the leadless pacing space, Boston Scientific (NYSE:BSX), is developing the Empower device to work alone or with its S-ICD pace, which uses subcutaneous instead of transvenous leads.
The post HRS 2016: Leadless pacers at the fore appeared first on MassDevice.
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