- Neovasc (NVCN) has experienced a setback with its Tiara TA transapical system’s European commercialization
- Tiara TA will be unable to receive a European CE mark under the current Medical Device Directive regulations ending on May 26, 2021
- The MDD will be replaced by the Medical Device Regulation on that date
- The company cannot provide the information required by its European Notified Body before the current MDD regulations end
- A CE mark would allow Neovasc to sell its Tiara TA system in Europe
- The company is collaborating with its European Notified Body on potential next steps
- Neovasc is a specialty medical device company that develops, manufactures and markets products for the cardiovascular marketplace
- Neovasc (NVCN) is down 9.17 per cent, currently trading at C$0.99 per share
Neovasc (NVCN) has experienced a setback with its Tiara TA transapical system’s European commercialization.
Tiara TA will be unable to receive a European CE mark under the current Medical Device Directive regulations ending on May 26, 2021.
The MDD will be replaced by the Medical Device Regulation on that date.
The company has determined that it cannot provide the additional information required by its European Notified Body, which includes further testing data, before the current MDD regulations end.
A CE mark under either the MDD or MDR regulations would allow Neovasc to commercialize the Tiara TA system in Europe.
The company is collaborating with its European Notified Body on potential next steps.
Fred Colen, CEO of Neovasc, commented,
“We are disappointed that the MDD regulations are going to be replaced before we are able to gain CE mark approval for the Tiara TA system. We believe that the Tiara valve has shown to be a remarkable device and we are pleased with the safety and efficacy profile the device has displayed in clinical trials to date.
Our team has worked tirelessly, and we believe we have made meaningful progress with our Notified Body during COVID-19 lockdowns to advance the approval process, but we have run out of time to complete the review before the transition to MDR next month, our previously announced target date for a CE mark decision.”
The transition from MDD to MDR does not impact the company’s Tiara transfemoral program.
Neovasc is a specialty medical device company that develops, manufactures and markets products for the cardiovascular marketplace.
Neovasc (NVCN) is down 9.17 per cent, currently trading at C$0.99 per share as of 2:42 pm ET.