Two products of Boston Scientific approved by the National Medical Products Administration through using Boao Lecheng’s real-world data !

Updated: March 5, 2022 L M S

On March 3, 2022, Boao Lecheng had again a breakthrough in using real world data for a medical device license application for Chinese Mainland! The National Medical Products Administration (NMPA), after examination, approved the application of the Boston Scientific water vapor thermal therapy system and its single-use prostate water vapor therapy system. This is the third and fourth innovative medical device respectively approved for registration by NMPA while using real-world data collected in the Boao Lecheng Pilot Zone in Hainan. This approval was preceded by the approval of a glaucoma drainage tube and a femtosecond laser ophthalmic treatment system. This Boston Scientific medical device uses hot water vapor to remove prostate tissue in order to reduce prostate volume and thereby alleviating obstruction and symptoms related to benign prostatic hyperplasia (BPH). The use of this medical device is suitable for patients of 50 years or over, who are suffering from benign prostatic hyperplasia. 

As stated, this device provides a new treatment method for benign prostatic hyperplasia and is more efficient and safer than traditional surgery. In the first place, the procedure can be carried out in an outpatient setting and patients do not need general anesthesia. Secondly, the duration of the surgery is short, on average lasting only 5-8 minutes. Compared with drugs or minimally invasive surgery, this device provides better treatment outcomes as it has a more stable curative effect of longer duration. In addition, the procedure results in fewer adverse reactions during the perioperative period with no serious sexual dysfunction after surgery. Furthermore, it can significantly relieve symptoms of the lower urinary tract while at the same time reducing the disease burden on middle-aged and elderly patients thereby contributing to healthy aging..