Medtronic Announces a Study on Its PFA Product---PulseSelectNew clinical research data. The study shows that two months after surgery,98% of pulmonary veins (PV) were persistently isolated, and all veins were isolated in 96% of patients.。
This study is a small-scale clinical trial involving 25 patients with persistent or paroxysmal atrial fibrillation (56% paroxysmal, 52% male, 69±9 years old) who received PulseSelect therapy.- Two months after the surgery, 98% of the pulmonary veins (102/104) achieved durable isolation, and 96% of the patients (24/25) achieved isolation of all veins;
- Two months after the surgery,No complications occurred;
- All index ablation procedures were performed using intracardiac echocardiography and electroanatomical mapping (EAM).No fluoroscopy required;
- Twenty-four of the 25 patients received general anesthesia, and all patients were discharged on the same day.
- The average procedure time was 36 minutes, with 100% of patients achieving acute pulmonary vein isolation.
"As the use of PFA for treating Afib rapidly increases, real-world evidence regarding chronic lesion formation and durability is critical, making these findings impactful and timely for the electrophysiology community."Our research shows that the use of PulseSelect leads to the formation of durable lesions, which is the cornerstone of successful pulmonary vein isolation and an important complement to the previously demonstrated safety and efficacy of this technology.”---Devi Nair St. Bernard's Medical Center"PulseSelect is the first PFA catheter in Japan to receive reimbursement approval based on clinical trial results, including those from Japanese patients. We believe the widespread use of this breakthrough technology within the insurance coverage will mark a significant milestone in the history of arrhythmia treatment in Japan."
---Hiroshi Tada University of Fukui
Executive Evaluation
"These important results clearly address the issue of durability and add real-world evidence for PulseSelect. With the expansion into new markets in the Asia-Pacific region, doctors around the world are experiencing the benefits of PulseSelect, including proven safety, efficacy, efficiency, and now durability. We are excited to offer this important tool to physicians for treating patients with atrial fibrillation."
---Rebecca Seidel, President of Cardiac Ablation Solutions Business, Medtronic Cardiovascular Portfolio
PulseSelectIt is the first PFA product to receive FDA approval. In addition to FDA approval, it has also been approved by multiple regulatory authorities such as CE and NMPA. MeanwhilePulseSelectIs second only toFARAPULSESubsequently, the second most used PFA catheter globally has now been administered to over 10,000 patients.PulseSelectTreatment.
PulseSelectIt is a new technology that utilizes pulsed electric fields to treat atrial fibrillation (AF), delivering bipolar, biphasic pulsed electric fields via a circular multi-electrode array catheter.PulseSelectConsists of five partsSteerable Multi-Electrode Circular Ablation CatheterPFA Host, ECG-Gated, Tableside Control, 10Fr Bidirectional Sheath.PulseSelectSteerable Multi-Electrode Circular Ablation CatheterUtilizing proprietary biphasic waveform, unique built-in guidewire, and 20° forward tiltDesign, which can support the operability, reliability, and safety of the surgery.According to Medtronic, a single pulmonary vein isolation procedure,The average total energy delivery time was 30 seconds to isolate all veins. Isolation time and capability have beenPULSED AF Proven in Large-Scale Clinical Trials.PulseSelectUsePulseRushElectric Field AblationOrCreate Damage and Scar Tissue，Interrupt Irregular Electrical Pathways in the HeartAnd atrial fibrillation triggers. However, unlike traditional ablation methods such as radiofrequency ablation or cryoablation,PulseSelectUsing non-thermal ablation methods, prioritizing cardiac tissue as the target,Selective targeting of cardiomyocytes, to avoid unnecessary damage to surrounding tissues, thereby avoiding complications caused by traditional ablation methods.
PulseSelect Demonstration
Medtronic is one of the largest medical technology, services, and solutions companies in the world, alleviating pain, restoring health, and extending life for millions of people globally. With over 90,000 employees worldwide, Medtronic serves doctors, hospitals, and patients in more than 150 countries. The company is committed to collaborating with stakeholders around the world to advance the healthcare industry.
