(Yicai Global) June 15 -- Despite Siemens Healthineers saying last month that it would suspend the use of CorPath GRX, the heart surgery robot gained marketing approval in China.

China’s National Medical Product Administration announced this month that it gave the okay for Siemens Healthineers' CorPath GRX to be marketed in the country. The regulator also noted that it will tighten the product's post-marketing supervision to safeguard patients.

Siemens Healthineers said last month that it had halted the use of CorPath GRX in cardiac surgery as it did not meet expectations. The firm's Chinese branch explained that the move was a strategic adjustment based on feedback from sales regions around the world, not because of any concerns about the product's safety, effectiveness, and supervision.

CorPath GRX is the first surgical robot to enter the innovation green channel, a fast-track approval process introduced by the NMPA in 2016 to speed the entry of innovative medical devices into the market, The Paper reported, citing Siemens Healthineers China.

“We have cooperated with the NMPA and accepted strict technical audits, inspection, and testing to fully verify the safety and effectiveness of the product despite a long review time,” the firm added.

CorPath GRX was the world's first robotic-assisted platform for endovascular surgery, developed by Corindus Vascular Robotics, a US medical robots business acquired by Siemens Healthineers for USD1.1 billion in 2019. Since then, it has been known as the vascular robotics division of Siemens Healthineers.

As of the third quarter of 2018, some 45 CorPath GRX systems were installed worldwide, over 95 percent of them in the United States. In the second quarter of 2019, eight more units were installed. But since Siemens Healthineers' acquisition of Corindus, the devices sales were barely mentioned in earnings reports.

Corindus is slow to operate, is less adaptable to surgical procedures, has fewer compatible consumables, and the price of its own consumables is high, The Paper cited industry insiders as saying.

Editor: Futura Costaglione