Boston Scientific Launches DIRECTSENSE™ Local Impedance Monitoring Technology in China
Boston Scientific
Medical Device Manufacturer
Shanghai, March 18, 2022 /PRNewswire/ -- On March 17, 2022, Boston Scientific, a global leading innovator in medical technology, announced the official launch of its DIRECTSENSE™ technology in China. The technology received approval from the National Medical Products Administration (NMPA) in January 2022. Integrated with the RHYTHMIA HDx™ Cardiac Mapping System, and used alongside the INTELLANAV™ MiFi OI Magnetic Navigation Ablation Catheter with microelectrodes and saline irrigation, it monitors local impedance changes during cardiac radiofrequency ablation procedures. AsCurrently the OnlyA tool capable of real-time monitoring of local impedance (resistance) changes near the ablation catheter tip, DIRECTSENSE technology will assist cardiac electrophysiologists in obtaining more genuine ablation feedback during procedures, thereby optimizing treatment.
Radiofrequency ablation is one of the common ablation treatments for arrhythmia, which releases high-frequency current locally to damage the target myocardial tissue through thermal effects. Real-time assessment of the ablation status during surgery is one of the key factors affecting the treatment outcome. In traditional radiofrequency ablation procedures, the evaluation of ablation effectiveness mainly relies on the operator's clinical experience, such as assessing through the contact force between the catheter and myocardial tissue, ablation power, and output duration. If there are deviations in the assessment, it may lead to incomplete ablation or excessive ablation, increasing the risk of recurrence and complications.
The DIRECTSENSE technology, which has been launched this time, can provide more timely and realistic feedback on tissue response to ablation. Combined with other monitoring parameters, the operator can intuitively understand tissue characteristics and the status of ablation lesions to better assess the real-time situation of the procedure and further optimize treatment outcomes.
DIRECTSENSE Technology: Utilizing a unique four-electrode method to measure the electric field changes of the ablation catheter electrode, it enables real-time monitoring and immediate feedback of local impedance changes near the catheter tip throughout the procedure. Before the operation, DIRECTSENSE technology helps doctors clearly understand tissue characteristics, allowing for precise and personalized surgical planning for patients. During the ablation process, the technology provides clearer real-time ablation feedback data, with a measurement range three times greater than traditional transthoracic impedance measurement techniques, and can measure cardiac tissue up to 4 millimeters in depth.[1], which can assist in providing feedback on the ablation level, reduce the risk of excessive ablation, and help shorten operation time. After the surgery, this technology can also help indicate the effectiveness of the ablation.
The positive impact of DIRECTSENSE technology on treatment is reflected in clinical research. A single-center retrospective study analysis involving 17 patients with typical atrial flutter showed that, compared with traditional force-sensing guidance, tricuspid isthmus ablation guided by local impedance feedback reduced ablation time by 47%, achieving a 100% acute success rate without complications; follow-up at 16 months post-operation showed no recurrence.[2]In addition, another single-center prospective study involving 157 patients with atrial fibrillation showed that when guided by local impedance drop data monitored using DIRECTSENSE technology, the first-pass isolation rate of the ipsilateral pulmonary veins reached 91.1%.[3]。
For patients with arrhythmia who do not respond to or cannot tolerate medication, catheter ablation is often the first-line treatment of choice. However, the普及速度 of ablation procedures in China remains relatively slow, leaving patient treatment needs largely unmet. Take atrial fibrillation (AF) as an example: it is estimated that there are currently over 10 million AF patients in China.[4]According to a survey by the Asia Pacific Heart Rhythm Society (APHRS), in 2020, only more than 50,000 atrial fibrillation ablation procedures were performed in mainland China.[5]The approval and future widespread application of DIRECTSENSE technology is expected to shorten the learning curve for cardiac electrophysiologists, thereby increasing the adoption rate of radiofrequency ablation procedures in China and benefiting more patients.
"Practicing the mission of 'innovating for life,' and precisely meeting the needs of different patients, has always been the driving force behind Boston Scientific's continuous innovation," said Ms. Zhang Jun, President of Boston Scientific Greater China. "From device hardware to technical software, we are constantly expanding our electrophysiology product portfolio to provide comprehensive electrophysiology treatment solutions for doctors and patients, while improving their accessibility. The rapid launch of DIRECTSENSE technology in China after its approval once again demonstrates Boston Scientific’s commitment to accelerating the introduction of innovative products to benefit Chinese patients and support the 'Healthy China 2030' initiative."”
About Boston Scientific
Boston Scientific Corporation is committed to innovation for life. We are dedicated to innovative medical solutions that improve the lives of patients around the world. For more than four decades, Boston Scientific has been at the forefront of the global medical technology industry, providing a wide range of high-performance medical solutions to meet the urgent needs of patients, and reducing healthcare costs. For more information, please visit the company's website:www.bostonscientific.cn
About Boston Scientific Greater China
Boston Scientific established its China headquarters in Shanghai in 1997 and currently has branch offices in Beijing, Shanghai, Guangzhou, Chengdu, Hong Kong, and Taiwan. The company's core business areas cover cardiac intervention, structural heart disease, cardiac rhythm management and electrophysiology, endoscopic intervention, peripheral and tumor intervention, urology and pelvic floor health, neuromodulation, respiratory products, and more. Upholding its tradition as an innovation leader, Boston Scientific is committed to becoming a respected medical technology company that meets the needs of doctors and patients, demonstrates innovative vitality, and provides high-quality medical products and services for prevention, diagnosis, and treatment. For more detailed information, please visit the company’s website:www.bostonscientific.cn
[1] Sulkin MS, Laughner JI, Hilbert S, et al. Novel measure of local impedance predicts catheter-tissue contact and lesion formation. Circ Arrhythm Electrophysiol. 2018 Apr;11(4):e005831.
[2] Saraf K, Morris GM. 231Local impedance-guided ablation and ultra-high density mapping provide improved ablation metrics vs conventional or contact force-guided ablation for cavotricuspid isthmus dependent atrial flutter. EP Eur. 2020;22(Supplement_1)
[3] Nakamura K, Sasaki T, Minami K, et al. Prevalence, characteristics, and predictors of endocardial and nonendocardial conduction gaps during local impedance-guided extensive pulmonary vein isolation of atrial fibrillation with high-resolution mapping. J Cardiovasc Electrophysiol. Published online July 13, 2021.
[4]Frost & Sullivan. "China Electrophysiology Devices Market Research Report".
[5] APHRS White Book 2021 https://aphrs.org/attachments/article/42/APHRS White Book 2021.pdf