Medtronic and Three Others Obtained NMPA Innovation Approval

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The NMPA granted Innovation Approvals to Medtronic and three others in May 2022:

  • Medtronic: Transcatheter Implantable Leadless Pacing System
  • Beijing Hengsheng: Disposable Intravascular Imaging Catheter
  • Beijing Hengsheng: Intravascular Imaging Equipment
  • Weiqiang: Thoracic Aortic Stent System
  • Beijing Pinchi Medical: Patient Programmable Charger

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. The patient’s cardiac activity is sensed in the right ventricle, the bradycardia rhythm is monitored, and pacing therapy is provided for the bradycardia.

The NMPA explained the reason behind the approval:

“Compared with traditional pacemakers, the system only needs to implant a single pulse generator in the ventricle to provide atrioventricular synchronized pacing, without the need for the subcutaneous pocket of the pacemaker and the venous connection to the atrium and ventricle. leads to reduce complications associated with the capsular bag and leads. Using this system allows a pacemaker to be implanted in patients with blocked veins because there is no need to pass the pacemaker leads through the vein or tricuspid valve.

The system adds mechanical sensing and atrioventricular pacing technology on the basis of the previous generation products and uses the built-in triaxial accelerometer to sense atrial mechanical signals in the ventricle to achieve atrioventricular synchronous pacing, which is compatible with the existing VVi single-ventricular pacing. AV synchronized pacing can increase blood volume in the ventricle compared to modalities, resulting in an increase in stroke volume per ventricular beat with corresponding clinical benefit.

The mechanical sensing and atrioventricular synchronized pacing technology in the leadless pacemaker adopted by this system is the first at home and abroad.”

Medtronic’s Clinical Pathway

Medtronic utilized the same variety comparison, with its own predicate device, and the 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 research, to demonstrate that the differences with the predicate device do not affect the clinical safety and effectiveness of the declared product.

For more information on Medtronic’s Clinical Pathway, please contact us or email info@ChinaMeddevice.com. We have the NMPA Evaluation Reports for 107 Innovation Devices. Please email us if there are any devices with Evaluation Report released.

Key Takeaways for Overseas Manufacturers

Overseas manufacturers need to bear in mind that:

  1. NMPA gives overseas manufacturers equal opportunity for the fast-track channels. No difference as to the qualifications for domestic manufacturers vs. overseas ones
  2. “Conditional Approval” applies for urgently needed medical devices. NMPA issue the “Guideline on Conditional Approval for Medical Devices” on December 20, 2019. It specifies that devices and IVDs indicated for life-threatening illnesses can be granted “Conditional Approval”, if the benefits of the products overweigh the risks, and the manufacturers are committed to do further clinical research
  3. They can initiate innovation approval applications at same time when applying China Patent & Trade Office coverage. Application does not have to be made after getting the patent
  4. Having been granted “status” does not mean “approval”. With ‘front-of-queue’ priority, they still need to go through the normal review process.

China Med Device has translated “Innovation Approval Procedure for Medical Devices” and other official NMPA documents into English as a service for its clients. Email info@ChinaMedDevice.com for details.

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