The NMPA granted Innovation Approval for a Peripheral Drug-Eluting PTA Balloon Catheter produced by Zylox Medical on November 11, 2020.
For the NMPA Innovation Device Review Report on the Peripheral Drug-Eluting PTA Balloon Catheter released on November 11, please email us at info@ChinaMedDevice.com.
Pre-clinical, Clinical and Risk-benefit Analysis
As NMPA standardize and streamline the review process for fast-track approvals, it is vital for manufacturers to comply with requirements of following items if you have similar stent system entering China market.
Pre-clinical
- Product performance research
- BC (biocompatibility)
- Sterilization
- Product expiration date and packaging
- Animal study
Clinical
The clinical trial was designed as a prospective, multicenter, randomized controlled trial, which was conducted in 15 different clinical institutions on 192 subjects.
The primary efficacy endpoint of the clinical trial was the late lumen loss in the target lesion after 6 months.
The safety endpoints were the incidence of major adverse events and device malfunctions.
Risk-benefit Analysis
This year has seen 30 innovation & priority review reports released. If you are interested in any device with pre-clinical, clinical and risk-benefit assessment information, please email us at ChinaMedDevice.com.
Significance of Peripheral Drug-Eluding Stent System
This product is suitable for percutaneous angioplasty in patients with femoral and popliteal artery (except for the subgenicular artery) stenosis or occlusion. The product dilates through balloon compression, mechanically dilating the narrow area of the blood vessel.
At the same time, the rapid release of paclitaxel in the drug coating inhibited intimal hyperplasia. This product is expected to improve the long-term patency rate of target vessels and improve the quality of life of patients.
