China NMPA granted Innovation Approvals to Medtronic and three other domestic manufacturers in May 2022:
- Medtronic: Transcatheter Implantable Leadless Pacing System
- Beijing Hengsheng: Disposable Intravascular Imaging Catheter, Intravascular Imaging Equipment
- Weiqiang: Thoracic Aortic Stent System
- Beijing Pinchi Medical: Patient Programmable Charger
Key Takeaways for Overseas Manufacturers:
Overseas and domestic manufacturers share equal opportunity in fast-track applications.
Manufacturers can initiate innovation approval applications while applying for China Patent & Trade Office coverage to shorten the review time. A shorter review time due to priority review of the innovation approval does not imply a shortened review process than a standard review.
Why NMPA Grant Innovation Approvals to Medtronic Device?
Medtronic's Transcatheter implantable leadless pacing system consists of an implantable pulse generator (fixed wings included) and a delivery catheter for detection and treatment of bradycardia.
The approval is granted based upon:
- Compared with traditional pacemakers, single pulse generator placement in the ventricle providing atrioventricular synchronized pacing eliminates the needs for subcutaneous pocket and venous connection.
- This system allows a pacemaker implementation in patients with blocked veins, because it no longer requires connections made through the veins or tricuspid valve.
- The system adds mechanical sensing and atrioventricular pacing technology compared to the previous generation products. It achieves atrioventricular synchronous pacing by sensing the atrial mechanical signals with its built-in triaxial accelerometer, and it also shares compatibility with the existing VVI single-ventricular pacing.
- AV synchronized pacing increases blood volume, resulting an increased stroke volume and leading to corresponding clinical benefit.
NMPA considers these add-on innovations in the leadless pacemaker to be the first at home and abroad.
Medtronic's Clinical Pathway for Innovation Approval:
Medtronic utilized the predicate comparison pathway with its own predicate device and its clinical trial for the clinical evaluation. The applicant combined the design verification, bench test of simulated condition, clinical literature with clinical trial data, and overseas post-marketing study, to demonstrate a minimal gap with the predicate device hardly affect the clinical safety and effectiveness of the declared product.
I would love to hear about your experiences and challenges on China medical device innovation applications.
------------------------------
Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------