Johnson & Johnson MedTech Receives CE Mark for New Cardiac Catheter Innovation
On January 10, 2025, Johnson & Johnson MedTech proudly announced that it has received the coveted CE mark for its innovative Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter, marking a significant advancement in the field of cardiac arrhythmia treatment. As a global leader in this arena, J&J MedTech's new catheter is designed to provide electrophysiologists with a powerful tool to effectively treat conditions like paroxysmal atrial fibrillation (AFib).
This latest catheter integrates both radiofrequency (RF) and pulsed field (PF) energy applications, giving physicians flexibility to customize treatment during procedures. Powered by the TRUPULSE™ Generator and fully integrated with the CARTO™ 3 System, the THERMOCOOL SMARTTOUCH™ SF Catheter is engineered for optimal performance, allowing seamless transitions between energy modes. Tom De Potter, M.D., Head of Electrophysiology at OLV Hospital, Aalst, Belgium, emphasized the global demand for such integrated and adaptable technologies, stating that they enhance both safety and efficacy in cardiac ablations.
The catheter's efficacy was underscored by results from the SmartfIRE clinical trial, where a remarkable 100% acute success rate was reported. The study highlighted that first-pass isolation of veins was achieved in an impressive 96.8% of cases using this technology, paving the way for improved patient outcomes.
While the CE mark opens the door for use in Europe, the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter is still awaiting approval in the United States. Nonetheless, Johnson & Johnson MedTech is actively working on expanding its reach. They have completed enrollment for the SmartPulse clinical trial in the U.S. involving 250 patients, aimed at evaluating the safety and effectiveness of the catheter in different clinical scenarios.
Additionally, the PulseSmart trial in Australia and Canada also reached enrollment completion, focusing on patients with drug-refractory PAF. These extensive studies aim to gather even more data supporting the device's innovative approach to treating AFib.
Dr. Dhanunjaya Lakkireddy, Executive Medical Director at Kansas City Heart Rhythm Institute, expressed the transformative potential of this catheter in simplifying ablation workflows and enabling personalized treatment plans tailored to individual patient needs. The integration with the CARTO™ 3 System provides real-time feedback on catheter performance, crucial for achieving effective lesion formation.
Johnson & Johnson MedTech is unwavering in its commitment to tackling complex health challenges, particularly in cardiovascular health. This latest development aligns with their broader strategy of offering a comprehensive portfolio of products engineered for compatibility and efficiency in treating cardiac arrhythmias. As the global landscape for affordable and advanced healthcare continues to evolve, innovations like the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter represent vital steps toward enhancing treatment outcomes for patients affected by AFib.
In conclusion, the launch of the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter exemplifies Johnson & Johnson MedTech's dedication to healthcare innovation, aiming to deliver effective and tailored solutions that meet ever-growing demands in cardiac treatment worldwide. As they continue to push the boundaries of medical technology, the anticipation builds for its broader adoption and the positive impact it will have on patient care globally.
Cutting-Edge Technology for Cardiac Ablation
This latest catheter integrates both radiofrequency (RF) and pulsed field (PF) energy applications, giving physicians flexibility to customize treatment during procedures. Powered by the TRUPULSE™ Generator and fully integrated with the CARTO™ 3 System, the THERMOCOOL SMARTTOUCH™ SF Catheter is engineered for optimal performance, allowing seamless transitions between energy modes. Tom De Potter, M.D., Head of Electrophysiology at OLV Hospital, Aalst, Belgium, emphasized the global demand for such integrated and adaptable technologies, stating that they enhance both safety and efficacy in cardiac ablations.
The catheter's efficacy was underscored by results from the SmartfIRE clinical trial, where a remarkable 100% acute success rate was reported. The study highlighted that first-pass isolation of veins was achieved in an impressive 96.8% of cases using this technology, paving the way for improved patient outcomes.
Expansion and Future Prospects
While the CE mark opens the door for use in Europe, the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter is still awaiting approval in the United States. Nonetheless, Johnson & Johnson MedTech is actively working on expanding its reach. They have completed enrollment for the SmartPulse clinical trial in the U.S. involving 250 patients, aimed at evaluating the safety and effectiveness of the catheter in different clinical scenarios.
Additionally, the PulseSmart trial in Australia and Canada also reached enrollment completion, focusing on patients with drug-refractory PAF. These extensive studies aim to gather even more data supporting the device's innovative approach to treating AFib.
Dr. Dhanunjaya Lakkireddy, Executive Medical Director at Kansas City Heart Rhythm Institute, expressed the transformative potential of this catheter in simplifying ablation workflows and enabling personalized treatment plans tailored to individual patient needs. The integration with the CARTO™ 3 System provides real-time feedback on catheter performance, crucial for achieving effective lesion formation.
Commitment to Cardiovascular Health
Johnson & Johnson MedTech is unwavering in its commitment to tackling complex health challenges, particularly in cardiovascular health. This latest development aligns with their broader strategy of offering a comprehensive portfolio of products engineered for compatibility and efficiency in treating cardiac arrhythmias. As the global landscape for affordable and advanced healthcare continues to evolve, innovations like the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter represent vital steps toward enhancing treatment outcomes for patients affected by AFib.
In conclusion, the launch of the Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter exemplifies Johnson & Johnson MedTech's dedication to healthcare innovation, aiming to deliver effective and tailored solutions that meet ever-growing demands in cardiac treatment worldwide. As they continue to push the boundaries of medical technology, the anticipation builds for its broader adoption and the positive impact it will have on patient care globally.
Topics Health）
【About Using Articles】
You can freely use the title and article content by linking to the page where the article is posted.
※ Images cannot be used.
【About Links】
Links are free to use.