(Yicai) May 30 -- Medical devices maker Boston Scientific said it has discontinued global sales of its transcatheter aortic valve replacement systems due to growing regulatory approval challenges in the United States and various other countries.

Boston Scientific has pulled its Acurate neo2, which was approved in China last year and launched last month, and Acurate Prime TAVR devices from the global market, it said in a filing with the US Securities and Exchange Commission on May 28.

The decision was made after "discussions with regulators which resulted in increased clinical and regulatory requirements to maintain approvals in global markets and to obtain approval in new markets," Boston Scientific said, adding that it will no longer seek approval from the US Food and Drug Administration or other regulators.

During clinical trials last year, Boston Scientific's TAVR systems failed to meet non-inferiority compared with other commercially available devices. In response, the firm said that the resources needed to meet increased regulatory requirements in the US and other countries had hindered its investment due to the need for new randomized clinical trials, the setup of registries, and extensive post-market activities.

In March, Boston Scientific said on WeChat that its Acurate neo2 valve had completed the first batch of implant surgeries in several top Chinese heart centers, including Zhongshan Hospital, an affiliate of Fudan University, the Second Affiliated Hospital of Zhejiang University School of Medicine, the Xiamen West China Hospital of Sichuan University, Beijing Anzhen Hospital, an affiliate of Capital Medical University, and Fuwai Hospital, an affiliate of the Chinese Academy of Medical Sciences.

The discontinuation of Acurate neo2 and Acurate Prime means that Boston Scientific's related investments have been wasted and will likely impact its finances. However, the company expects its second-quarter and annual sales and adjusted net profit to be within an expected range.

"Boston Scientific's TAVR business is not large, and the impact of its withdrawal from the market is limited," a cardiologist who participated in the first batch of clinical implants of Acurate neo2 in China told Yicai.

The number of TAVR procedures in China reached 17,232 last year. After Boston Scientific's exit, US' Edwards Lifesciences and Ireland's Medtronic remain the only overseas firms in the Chinese TAVR market, with domestic manufacturers dominating the market.

Although Boston Scientific has a significant presence in the cardiovascular market, its heart valve products are limited, with its relevant revenue mainly coming from pacemakers and stents. It has also expanded into the left atrial appendage closure and atrial fibrillation treatment markets with its Watchman and Farapulse devices.

Editor: Martin Kadiev