Is Boston Scientific Worried About Paclitaxel and Vaginal Mesh Headwinds?

Boston Scientific had a lot to celebrate this week after FDA approved the company's much-anticipated Lotus Edge Valve for transcatheter aortic valve replacement. But enthusiasm for the approval was dampened during the company's first-quarter earnings call Wednesday by recent regulatory setbacks. The company is feeling the impact of ongoing Paclitaxel concerns, FDA's recent decision on vaginal mesh products, and the shutdown of an Illinois sterilization plant that previously sterilized products in Boston Scientific's men's health business. Here's a look at how each of these issues has impacted Boston Scientific, and how the company plans to address each of these revenue headwinds. Expect Slower Adoption of Eluvia Due to Paclitaxel Concerns What Happened: First, to recap, Boston Scientific received FDA approval in September 2018 for its Eluvia paclitaxel drug-eluting stent for the treatment of peripheral artery disease. The device was expected to be a key growth driver for the company's peripheral interventions (PI) business, but paclitaxel balloons and stents received some bad press in January after a meta-analysis showed an increased risk of death for patients treated with these devices. After conducting a preliminary analysis of long-term follow-up data (up to five years in some studies) of the pivotal premarket randomized trials for paclitaxel-coated products indicated for PAD, F...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Cardiovascular Source Type: news