Biosense Webster’s THERMOCOOL SMARTTOUCH SF Ablation Catheter Approved by FDA
 

Biosense Webster’s THERMOCOOL SMARTTOUCH SF Ablation Catheter Approved by FDA
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Biosense Webster, a part of J&J, is releasing its*THERMOCOOL SMARTTOUCH*SF Catheter in the U.S. following FDA approval. The device is used along with the company’s flagship CARTO 3 during cardiac ablation procedures to treat atrial fibrillation.

The catheter is delivered in a minimally invasive fashion into the heart with the help of the CARTO 3 system that lets clinicians visualize the live location and orientation of the catheter, and so minimize the patient’s radiation exposure from fluoroscopes.

The*THERMOCOOL SMARTTOUCH*SF has a deflectable porous tip with contact force activation that helps to make sure the device is pressed securely against the targeted tissue before ablation can begin. The evenly distributed cooling coupled with contact force tech**logy helps surgeons to position and activate the device faster, and lead to more consistent ablations and shorter procedure times.

From*Biosense Webster’s an**uncement:

Clinical data has demonstrated the safety of the device when used to treat drug refractory paroxysmal atrial fibrillation. The SMART-AF trial, a multicenter, prospective study of the earlier generation THERMOCOOL SMARTTOUCH® tech**logy, revealed ** unanticipated adverse events and demonstrated a success rate of greater than 80 percent, with increased stability within the contact force range.*The more recent SMART-SF study, which tested the newest generation THERMOCOOL SMARTTOUCH® SF Catheter, demonstrated excellent safety results as well.*The study found an 18.7 percent reduction in overall procedure time and a 14.2 percent reduction in overall ablation time when compared to the SMART-AF study. It also demonstrated a 55.2 percent reduction in total fluoroscopy time, limiting radiation exposure to patients.

Source: Biosense Webster…

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