Abbott (NYSE:ABT) said today that the TactiCath sensor-enabled ablation catheter it bought along with St. Jude Medical (NYSE:STJ) this year won CE Mark approval in the European Union.
The Chicago-area healthcare giant said the new TactiCath device can be integrated with another St. Jude product, the EnSite Precision heart mapping system it launched earlier this year.
“The goal in developing the TactiCath contact force ablation catheter, sensor enabled, was to provide the most innovative solution for treating atrial fibrillation and lead the way in clinical outcomes for patients with cardiac arrhythmias – even during long and complex ablation procedures,” electrophysiology medical director Dr. Srijoy Mahapatra said in prepared remarks. “Integration with the EnSite Precision cardiac mapping system provides an unprecedented opportunity to help patients suffering with atrial fibrillation.”
Abbott said it’s planning a full market release during the 3rd quarter, after launching the device in “select” European countries, and is pursuing FDA approval.
“TheTactiCath contact force ablation catheter, sensor enabled, along with the EnSite Precision cardiac mapping system, create a powerful combination for more precisely treating patients with cardiac arrhythmias,” added Dr. Martin Lowe of London’s St. Bartholomew’s Hospital. “Feeling confident in the accuracy of the contact force reading allows me to target the optimal pressure for creating effective and safe lesions.”
Abbott said studies show that the device delivered clinical success in 85.5% of patients and fewer post-ablation clinical events, for a 15% reduction in post-ablation management costs or about $3,400 per patient at 1 year compared with treatment with a non-contact force catheter.
St. Jude in August 2013 agreed to pay up to $331 million, including $170 million in up-front cash, for Swiss force-sensing catheter maker Endosense.
