How Abbott is Putting St. Jude Tech to Work

Posted in Cardiovascular by Nancy Crotti on May 11, 2017

The company integrated St. Jude’s EnSite Precision cardiac mapping system into its new contact force ablation catheter for atrial fibrillation.

Nancy Crotti

Abbott's latest innovation to treat atrial fibrillation, the TactiCath contact force ablation catheter, is integrated with St. Jude's EnSite Precision cardiac mapping system.

 

Abbott is wasting no time in employing technology acquired as part of its $25 billion purchase of St. Jude Medical.

Learn from product design experts at the MD&M East Conference & Expo, June 13-15, 2017, in New York City.

Abbott recently landed the CE Mark for its sensor-enabled TactiCath contact force ablation catheter, developed to treat atrial fibrillation (AF), a condition in which the upper chambers of the heart beat too fast. Integrated with St. Jude’s EnSite Precision cardiac mapping system, TactiCath enables physicians to use dual impedance and magnetic technologies to more precisely model the heart than a catheter without a sensor could, according to a statement from Abbott.

FDA approved EnSite in December, just a couple of weeks before Abbott closed on the St. Jude deal. In its fourth-quarter earnings call, Abbott executives touted EnSite as as a key growth driver for the company's electrophysiology business.

Arrhythmias develop when electrical signals that regulate heart rhythms become disrupted or change, making the beat irregularly. A patient with AF is at increased risk for stroke because the rapid heartbeat can let blood pool in the heart, which can cause clots to form and travel to the brain. To restore optimal electrical signals in the heart, ablation catheters deliver radio-frequency energy to cardiac tissue, creating small scars or lesions to areas responsible for generating arrhythmias.

Not all ablation technology is the same, however, and recent research has continued to show the importance of applying optimal contact force (pressure) to the heart during ablation procedures, according to Abbott’s statement. Too much pressure applied to heart tissue can result in complications, yet if not enough pressure is applied, the lesion may not be effective enough to stop the erratic signals in the heart.

EnSite enables TactiCath users to visualize the contact force exerted to create a lesion. Abbott said it pioneered the new device’s fiber optic sensing technology in its original TactiCath device. Before that, physicians had to use other means to assess whether the catheter was in contact with the heart tissue, Justin Paquette, an Abbott spokesman, told Qmed. This ranged from catheter feel, to intracardiac imaging, to fluoroscopy (x-ray) exposure, to the patient, and the procedure personnel.

“The only thing this provided was feedback on the tip-to-tissue contact, not the strength of the contact,” Paquette said. “If there was too little contact, the efficacy of the lesion could be compromised leading to arrhythmia recurrence and the need for another procedure.  If the contact was too strong, it could lead to a safety event such as a cardiac perforation.”

The original TactiCath technology, approved in Europe in 2012 and by FDA in 2014, remains the same, but now physicians can customize the contact force information window and automatic setup of lesions, based on their preference of several parameters, including contact force, Paquette added.

The sensor-enabled TactiCath is available in limited markets in Europe, with a full rollout expected in the third quarter. Abbott is pursuing approval in the U.S.

Nancy Crotti is a contributor to Qmed.

 

[Image credit: Abbott Laboratories]