Nippon Medical School

Integrated with Varipulse Catheter, Trupulse Generator, and CARTO 3D cardiac mapping system, Varipulse is said to be the first and only PFA system approved in Japan for the treatment of symptomatic drug refractory recurrent paroxysmal AFib Varipulse Platform comprises Varipulse Catheter, Trupulse Generator, and Carto 3D cardiac mapping system. (Credit: PRNewswire/ Biosense Webster) Biosense Webster, a part of Johnson & Johnson MedTech, has received Japan’s Ministry of Health, Labour and Welfare (MHLW) approval for its Varipulse pulsed field ablation (PFA) platform. The PFA platform is intended for the treatment of symptomatic drug refractory recurrent paroxysmal atrial fibrillation (AFib). It comprises a Varipulse Catheter, a variable-loop multielectrode catheter; Trupulse Generator, a multichannel PFA generator; and CARTO 3 System, a 3D cardiac mapping system. Varipulse platform is said to be the first and only Carto-integrated PFA system that enables an intuitive and reproducible workflow with real-time visualisation and feedback mechanisms. Biosense Webster president Jasmina Brooks said: “At Biosense Webster, we are working to deliver a differentiated PFA portfolio integrated with 3D cardiac mapping to address the real-world, unmet needs of electrophysiologists and the patients they treat. “Today, we celebrate this milestone approval of the Varipulse Platform, the first and only PFA system approved in Japan. “We are excited to continue to advance PFA clinical studies globally and look forward to the positive impact this innovation will deliver to patients everywhere.” Catheter ablation is a minimally invasive procedure to treat heart rhythm disorders, including AFib, by delivering heat (radiofrequency ablation) or cold (cryoablation). PFA represents a new approach to treating AFib, which uses a controlled electric field to selectively ablate cardiac tissue that causes irregularity in the heartbeat. It leverages the irreversible electroporation (IRE) process to deliver the electric field, which reduces the risk of damage to surrounding tissues. The Varipulse PFA platform has been evaluated in the inspIRE clinical trial in Europe. Early results from the study showed a one-year clinical success of 78.9%, defined as freedom from documented symptomatic atrial arrhythmia recurrence. The clinical trial also showed a notable safety profile, with no primary adverse events reported. The platform’s unique pulse sequence, catheter design, and CARTO 3 System integration enabled a simplified workflow and effective procedures, said the medical device company. Nippon Medical School department of cardiovascular medicine professor and Japan Heart Rhythm Society president Wataru Shimizu said: “The approval of ablation therapy using pulsed-field energy in Japan will further advance the treatment of arrhythmias. “Together with the integrated 3D mapping system, this innovation has the potential to provide more advanced treatment and further improve safety. “The increasing diversity of treatment technologies means that healthcare providers who seek to cure atrial fibrillation have options tailored to each patient’s condition.”

This announcement follows last week’s 96th Annual Meeting of the Japanese Orthopaedic Association in Yokohama, Japan, where Exactech presented new research that showcases the ability to acquire joint laxities in the knee when using Newton over conventional techniques Exactech Accelerates International Expansion of Its Newton Balanced Knee Technology (Credit: Business Wire) Exactech, a developer and producer of innovative implants, instrumentation, and smart technologies for joint replacement surgery, announced plans to accelerate the expansion of the Newton Knee to the Asia-Pacific region. This announcement follows last week’s 96th Annual Meeting of the Japanese Orthopaedic Association in Yokohama, Japan, where Exactech presented new research that showcases the ability to acquire joint laxities in the knee when using Newton over conventional techniques. One of the first surgeons to use the Newton Knee, Hiroshi Watanabe, MD, with the Nippon Medical School Musashikosugi Hospital in Kanagawa Prefecture, commented, “Total knee arthroplasty with navigation technology requires an optimal balancing technique to ensure the suitable knee laxity and motion. Exactech’s Newton technology and its tibia-first technique is the most promising solution to help solve those issues and evaluate the knee laxity more precisely.” The Newton Knee technique focuses on enhancing the surgical experience by providing valuable gap balance data to help achieve reproducible balance in total knee replacement procedures. Unlike other technologies, the Newton Knee technique utilizes a dynamic tensor to acquire real-time soft tissue data throughout the full arc of motion. Working in concert with the company’s pioneering ExactechGPS system, this powerful technology helps visualize postoperative joint balance and stability to help execute a personalized positional plan before any bony resections are performed. “Exactech is focusing its efforts and investments on unique surgical technologies that can most significantly improve clinical outcomes,” said Darin Johnson, Exactech President and Interim CEO. “The Newton balanced knee system provides surgeons with a robust platform of patient-specific insights that otherwise may not be available. Expanding access to this advanced technology into the APAC region is important for our company strategically, and for the surgeons and patients who can now benefit from this innovation.” Source: Company Press Release

Singapore's National Neuroscience Institute has partnered with VR medical content platform Kyalio to develop neurosurgery training modules. As part of their research collaboration agreement, they have created VR modules based on real-life cases managed by neurosurgeons at NNI and captured by Kyalio. The modules can be viewed through an Oculus VR headset or a mobile VR viewer. WHY IT MATTERS During the pandemic, medical professionals who sought to learn neurosurgery in Singapore had to postpone their training as border closures prevented them from entering the country. This only compounds the problems faced by countries where there are only a few skilled neurosurgeons. Moreover, medical students and doctors in such countries "rarely" have the chance to have hands-on experience in the operating theatre. "Many countries have exponentially increased the output of new doctors but experienced doctors who lead training in these countries remain far fewer and training methods have to become ‘high yield’ in nature," noted Samuel Choo, co-founder of Kyalio. The VR modules developed by the NNI and Kyalio support the continuing education and upskilling of those medical doctors and students by providing them with a simulated experience of various neurosurgical procedures. "This allows them to experience the important steps of the operation, hear discussions related to the procedure, and ‘look around’ the operating room to see the setup and team dynamics. The virtual reality environment also gives a realistic appreciation of the surgical anatomy, something that 2D videos cannot achieve," the NNI said in a statement. The organisations aim to create a library of at least 100 neurosurgery training modules on Kyalio, covering a diverse set of cases. Currently, Kyalio has training modules in craniotomies, brain tumour resections, as well as neurovascular and neurospine surgeries, which are being used by over 1,000 learners across Southeast Asia, India and Africa. THE LARGER TREND This collaboration with the NNI follows Kyalio's partnership with the National Cheng Kung University College of Medicine in Taiwan which started in February. They also sought to create VR content on various medical procedures. Aiming to help continue clinical training during the pandemic, Japanese VR company Jolly Good partnered with the Nippon Medical School in Japan to develop a cloud-based clinical education platform that uses its VR system. Another VR firm, Vantari VR , recently tied up with Australian tertiary care hospitals to accelerate the training of their junior doctors and trainees for critical care. It provides modules that cover 90% of medical procedures that are recommended by college guidelines.