Johnson & Johnson's HELIOSTAR™ 3D Multi-Channel RF Ablation Balloon Catheter Enters China's Fast-Track Approval Pathway

SHANGHAI, May 31, 2018 /PRNewswire/ -- Johnson & Johnson Medical today announced that its HELIOSTAR™ Three-Dimensional Multi-Channel Radiofrequency Ablation Balloon Catheter has recently received approval from the National Medical Products Administration to enter the Special Review Procedure for Innovative Medical Devices. This "green channel" will accelerate the market launch of HELIOSTAR in China, while also paving a new path for faster introduction of more Johnson & Johnson Medical products to the Chinese market.

The HELIOSTAR 3D Multi-Channel Radiofrequency Ablation Balloon Catheter is currently in the development stage and has not yet completed registration in any country worldwide. It is indicated for cardiac electrophysiological mapping and can be used in conjunction with a multi-channel radiofrequency ablation generator to treat drug-refractory paroxysmal atrial fibrillation. As China's first medical device to enter the "Green Channel" for innovative medical device approval”The accelerated launch in China of the three-dimensional, multi-channel radiofrequency ablation balloon catheter, HELIOSTAR, will directly benefit over 10 million atrial fibrillation patients in China, along with the growing number of new cases. It will shorten the learning curve for young physicians, improve treatment rates and clinical outcomes for atrial fibrillation patients, enhance patients’ quality of life, and set a new standard for atrial fibrillation treatment in China.

Since 2014, the Chinese government has continuously deepened reforms of the review and approval system to encourage research and innovation in medical devices and promote the dissemination and application of new medical device technologies. Notably, the Special Approval Procedure for Innovative Medical Devices establishes a dedicated “green channel” for technical review and administrative approval of such devices. It also permits imported products to be registered without submitting documentation from the competent authority in the applicant’s home country (or region) certifying market authorization for the medical device, thereby enabling simultaneous registration and approval in China and the country of origin.

“We are delighted to see that Johnson & Johnson MedTech’s innovative technology has received approval through the government’s green channel. With accelerated registration, patients in China will gain earlier access to this breakthrough product,” said Song Weiqun, President of Johnson & Johnson MedTech China.

As one of the severe challenges facing the global cardiovascular disease field in the 21st century, atrial fibrillation and its complications significantly impair patients’ quality of life and threaten their safety, while imposing a substantial economic burden on both patients and society. While facilitating the entry of the HELIOSTAR 3D Multi-Channel Radiofrequency Ablation Balloon Catheter into the expedited approval pathway to accelerate its market launch, Johnson & Johnson has also supported the establishment of atrial fibrillation centers at major hospitals since February this year, thereby helping to usher China’s diagnosis and treatment of atrial fibrillation into a new era.