Boston Scientific chides EU docs for unsupervised Lotus valve implants

Boston Scientific (NYSE:BSX) today released a field safety notice warning after an investigation identified that a “number of sites” had been performing procedures with the Lotus Valve System without an appropriately trained field clinical specialist.

The Marlborough, Mass.-based company said that the presence of a Boston Scientific field clinical specialist is required unless a site is designated as “independent” by the company. Independent site designation requires 2 physicians undergo face-to-face training, perform a minimum of 6 lotus valve procedures with a proctor and an additional 4 valve implants with FCS supervision.

No products are being recalled and that the warning comes with no impact on previously implanted devices, according to the safety notice.

The company also warned of a potential for device damage during preparation that could be missed during an inspection prior to a procedure. The issue involves the device’s ‘release mandrel’ component, which extends through the valve, and can become damaged during sheathing due to crimping at the midsection.

A crimping in the mandrel increases the risk of breaking during the procedure, which would prevent the valve from being released by the delivery system, the company said. However, the device can still be safely removed if the error occurs through resheathing the valve.

Boston Scientific said the most common outcome from a broken release mandrel is a prolonged procedure and the necessity of replacing it with a new device. The company said it will update its training information to avoid mandrel damage during preparation.

Last June, data from a study of  Boston Scientific’s Lotus Valve showed a greater device success rate than Medtronic‘s (NYSE:MDT) CoreValve in high-risk transcatheter aortic valve replacement patients.

The single-center, non-randomized study, published this month in the journal JACC: Cardiovascular Interventions, compared outcomes from 50 high-risk TAVI patients treated with the Lotus valve and 50 similar patients treated with Medtronic’s self-expanding CoreValve device.

Success rates were higher at 30 days in the Lotus group, at 84%, versus 64% with CoreValve, according to the study.  These results were driven by higher rates of correct positioning and no more than mild aortic regurgitation, according to the study.

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