Roller Coaster for Boston Scientific

Company gets approval on aortic valve, stop order on mesh

There is good news and bad news from the FDA for Boston Scientific, and it seems that the bad news is hurting profits. As Conor Hale of Fierce Biotech put it, “What the FDA gives, it can also take away—and in the past week, Boston Scientific has seen both.”

On the positive side, the FDA has approved the Boston Scientific’s long-awaited Lotus Edge aortic valve system for high-risk patients, Hale reported. Currently, the transcatheter replacement system is the only FDA-approved heart valve that enables surgeons to “reposition or recapture the valve after it has been fully deployed.”

Boston Scientific’s newly approved Lotus Edge heart valve has a braided frame and an adaptive seal that is designed to minimize leaks by conforming to the patient’s heart valve. The company started a controlled launch of the Lotus Edge in Europe in March and is planning to do the same in the U.S. in the near future.

Kevin Ballinger, global president of interventional cardiology at Boston Scientific, said, "Bringing the much-anticipated Lotus Edge valve system to market allows us to provide patients who aren't good candidates for traditional surgery a safe and effective treatment alternative to restore proper function to their severely narrowed aortic valve."

However, the FDA also ordered Boston Scientific, along with device maker Coloplast, to immediately stop the sales of transvaginal mesh used to repair pelvic organ prolapse. The ruling came after many years of safety reports, lawsuits and settlements related to the procedure.

Boston Scientific’s transvaginal mesh products include the Uphold Lite Vaginal Support System, Xenform Soft Tissue Repair Matrix, Pinnacle Lite Posterior and Polyform devices. While the company was “deeply disappointed” by the FDA’s decision, it is going to stop both U.S. and international sales of these products. Still, the FDA’s order does not apply to surgical mesh used to treat stress urinary incontinence or transabdominal repair, so Boston Scientific can continue in those areas.

Both scenarios played out just as the company released its first-quarter earnings report. The company just missed analysts’ expectations, with shares going down as much as 4 percent in premarket trading. Boston Scientific had $2.493 billion in sales, for a growth rate of 4.8 percent on a reported basis, 6.3 percent when eliminating currency fluctuations and sales from the company’s 2018 acquisitions of NxThera, Claret Medical and Augmenix, which had no comparable sales for 2017.

The company also reported that adjusted earnings per share for the quarter reached $0.35, better than last year’s $0.33, but one cent below Wall Street’s expectations. Boston Scientific also narrowed and lowered its guidance for the year, to 7 to 8 percent growth, compared to the 7 to 9 percent it predicted last quarter. The company’s stock ended up within a percentage point of the previous close, at around $35.55.

According to Boston Scientific Chairman and CEO Mike Mahoney, "Our global team and differentiated portfolio enabled us to deliver good sales and earnings growth this quarter, despite some revenue softness compared to our estimates. With our strong pipeline and category leadership strategy, we are confident in our top tier 2019 outlook and how we can help improve outcomes for patients around the world for years to come."

Boston Scientific had growth in all segments as compared to last year’s first quarter. Its MedSurg division led with a 7.7 percent increase, compared to 2.8 percent in rhythm and neuromodulation devices and 4.2 percent in cardiovascular products.



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