In July, Vancouver-based Neovasc said it hoped the get the device on the U.S. market in early 2020 via a humanitarian device exemption. Reducer is designed to narrow the coronary sinus to treat refractory angina.
Today the company said that, after its last Oct. 9 discussion with the FDA and “weighing all available options,” it decided to pursue a PMA for Reducer.
“While any pathway to U.S. market approval by the FDA carries considerable risk, we believe the full PMA application pathway brings the best chance of success within reasonable cost and time constraints. After evaluating the different options, we concluded that the humanitarian use device pathway would likely not be a viable option based on the definition of an HUD device within the FDA guidance and that the PMA pathway would be our best option to bring Reducer to the U.S. market to treat refractory angina patients. While an additional post-market study will most likely be needed and the body of real-world evidence continues to grow, the company believes that the clinical evidence already available will be sufficient to not further delay the availability of this breakthrough medical device for the treatment of U.S. patients,” president & CEO Fred Colen said in prepared remarks.
“We believe that the totality of clinical evidence from the Cosira study, [the] Reducer-I European post-market study (with over 200 of 400 patients enrolled) and multiple independent studies published in peer-reviewed journals will provide reasonable assurance of safety and effectiveness to support a PMA. Neovasc plans to submit the PMA application prior to the end of 2019 with a request for an advisory panel meeting,” Colen said.
NVCN shares were down -4.4% to $3.74 apiece today in noontime trading.