Boston Scientific has announced a delay to the previously communicated timelines for the commercialisation of its Lotus Edge transcatheter aortic valve implantation (TAVI) device in Europe and the USA. Originally, the company said it hoped to re-introduce the device in Europe by early next year.
After initiating a voluntary recall for the Lotus and Lotus Edge systems earlier this year, Boston Scientific implemented manufacturing process and design specification changes to the Lotus Edge delivery system with the intent of re-introducing the product in Europe by the first quarter of 2018 and filing the final pre-market approval (PMA) module with the US FDA by January 2018.
However, a press release reports that the company now expects to provide an update on the status of the Lotus Edge valve during its fourth quarter 2017 earnings conference call on 1 Februar 2018, as it continues to focus on manufacturing and regulatory milestones to support the long-term success of the Lotus platform.
Mike Mahoney, chairman and chief executive officer, Boston Scientific, comments: “We continue to see value in the unique benefits of the LOTUS Valve platform in treating patients with aortic stenosis. While we are disappointed in this delay to our timelines, we are working to carefully analyse and implement necessary modifications to pass our rigorous internal quality standards.”
Boston Scientific has said will continue to work closely with the US and European regulatory bodies to share pertinent updates about these delays and impact to submission timing. The present announcement is not expected to have a material financial impact to Boston Scientific fourth quarter or full year 2017 guidance.