Edwards Lifesciences’ Transcatheter Aortic Valve System Obtained NMPA Innovation Approval

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Edwards Lifesciences’ Transcatheter Aortic Valve System Obtained NMPA Innovation Approval

NMPA granted Innovation Approval to Edwards Lifesciences’ Transcatheter Aortic Valve System on June 8. It is the 14th device obtained such approval in 2020.

Balloon Technology

The product includes transcatheter aortic valve, transcatheter aortic valve delivery system, catheter sheath kit, transfemoral balloon catheter, and valve presetting device. The valve consists of bovine pericardial leaflets, cobalt-chromium alloy frame, and PET inner and outer skirts. It is intended for high-risk or contraindicated surgical procedures on patients with severe calcified autologous aortic valve stenosis.

NMPA sates in the approval notice that “the product adopts balloon expansion technology. The valve frame can provide high radial support force, while the low valve frame height is adapted to the surrounding anatomy, and the risk of pacemaker implantation is reduced; the paravalvular regurgitation is decreased through the outer skirt design. The incidence of paravalvular leaks is expected to be lower in clinical applications.”

Overseas Clinical Data

For clinical evaluation, Edwards Lifesciences went through the pathway of Overseas Clinical Data Acceptance.

The applicant provided overseas PIIS3HR cohort clinical trial data. The overseas data is supported by clinical trial data and literature review of the device and its similar predicates, which demonstrated that the genetic differences do not pose safety and efficacy issues.

We have the NMPA Evaluation Reports for 72 Innovation Devices granted since November 2017. For our comments on 2019 reports, please click HERE.

Key Takeaways for Overseas Manufacturers

Only one out of five medical devices granted Innovative Device Status (not approved yet) by NMPA in 2019 were imported. Since domestic and overseas manufacturers have equal opportunity for this program, U.S. and European companies may not be taking full advantage.

Of the 39 innovation device status in 2019, only eight (just about 20%) were imported devices. One of those is Cardiovascular Systems, a company represented by China Med Device, LLC. China Med Device also conducted clinical trials for United Imaging’s CT-Linac (Click HERE), a combination of CT and accelerator for cancer radiotherapy. NMPA granted Innovation Approval to CT-Linac in December 2018. Email info@ChinaMedDevice.com to see if you are qualified to apply.

Overseas manufacturers have 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 have 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.