Boston Scientific, according to a press release announcing the company’s Q1 2020 financial results, has received the CE mark for its Acurate neo2 aortic valve system. The press release reports that the transcatheter aortic valve implantation (TAVI) system builds on the clinical performance of the original Acurate neo platform.
As well as reporting the CE mark, press release states that Boston Scientific received US Food and Drug Administration (FDA) for the DirectSense RF device. It states that this is the only tool available to monitor the effect of radiofrequency energy delivery via changes in local impedance around the tip of a catheter during cardiac ablation procedures.
Regarding the financial results, the press release notes, the company generated sales of US$2.543 billion during the first quarter of 2020; this represents growth of 2% on a reported basis, 3.2% on an operational basis and a decline of 2.9% on an organic basis (all compared to the prior year period).
Mike Mahoney, chairman CEO, Boston Scientific, comments: “During this global pandemic, we are grounded in the urgency of providing important medical products and therapies to those who need them—in particular, many patients with acute needs. We continue to balance short-term adjustments to our plans while strengthening our long-term strategy to serve our customers and deliver high performance. I am confident in our ability to bring meaningful, innovative products to market, and grateful for our team’s winning spirit as we navigate the impact of these challenges.”
In terms of its approach to helping address the challenges of the COVID-19 pandemic, Boston Scientific’s efforts include collaborations with the University of Minnesota and others to develop the Coventor, an emergency resuscitator granted Emergency Use Authorization by the FDA, and a reusable personal respirator, as well as the production of face shields for frontline healthcare workers.