Sunday 17 December 2017

Boston Scientific recalls Irish-made heart devices

Boston Scientific’s global headquarters in the United States
Boston Scientific’s global headquarters in the United States

Natalie Grover

Boston Scientific said on Thursday it was recalling its Lotus range of heart devices, which are made at its Galway plant, sending its shares down 7.3pc in morning trading.

The products - which have problems with the locking mechanism - are expected to return to the European market and other regions in the fourth quarter, the company said. It noted the issue was caused by excess tension in the pin mechanism introduced during the manufacturing process.

The company's Lotus technology is used in transcatheter aortic valve replacement (TAVR), a minimally-invasive procedure designed to replace a narrowed aortic valve that fails to open properly.

Boston Scientific had suspended implants of its next-generation Lotus Edge device in Europe last October over similar concerns, but last month said it had found a fix for the issue. The company has pushed the submission of its marketing application for the device in the United States to the fourth quarter, and expects to launch it in mid-2018.

This should give longer-term holders the confidence that this is a solvable issue and that Boston Scientific is taking a very conservative approach (as suggested by the timeline delay) in getting this right, said Evercore ISI's Vijay Kumar.

In January, the company said it expected to make the submission in May and launch by the end of 2017.

While the delay is no doubt disappointing, the technology continues to be a meaningful opportunity over the medium term, Kumar said.

The TAVR market could potentially exceed $5bn by 2021, and grow 10pc to 15pc for the foreseeable future, Leerink analysts said in a note on Thursday. (Reuters)

Irish Independent

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