Lotus Edge

Main article: Artificial heart valves

2020: Recall defective heart valves and stop Lotus program

In mid-November 2020, Boston Scientific began recalling Lotus Edge defective aortic valves for transcatheter implantation and stopped the Lotus program. The company said that it recalls unused products solely due to problems with the delivery system, although the implantation of an artificial valve itself allows you to achieve clinically significant favorable results. According to the company, patients who have already been implanted with the Lotus Edge valve are not afraid to build.

Given the additional time and investment needed to develop and re-implement the enhanced delivery system, Boston Scientific representatives decided to abandon the Lotus promotion program and discontinued all related commercial, clinical, research and manufacturing operations. Boston Scientific expects the termination of the Lotus program to result in losses ranging from $225 million to $300 million. Most of the costs will fall on the fourth quarter of 2020.

While we were satisfied with the benefits that the Lotus Edge valve provided to our patients, we increasingly faced complaints from physicians about the excessive complexity of the delivery system, explained Boston Scientific Chairman and Chief Executive Officer Mike Mahoney. - The complexity of the delivery system, production problems, the constant need for further technical improvements and the current pace of decision-making in the market have led us to a difficult solution - we have stopped investing in the Lotus Edge platform. Instead, we will focus our resources on developing the Acurate neo2 artificial aortic valve system, Sentinel cerebral embolism protection system, and other products in our portfolio.[1]

2019: Start of sales after regulatory approval

At the end of April 2019, Boston Scientific received regulatory approval to release the Lotus Edge artificial aortic valve for transcatheter prosthetics. Previously, only two companies operated in this market - Edwards Lifesciences and Medtronic. Now they are joined by Boston Scientific.

The Lotus Edge device at the development stage aroused interest among medical and analytical communities, since it belongs to the generation of artificial valves with minimal transclap regurgitation. And Lotus Edge not only maintains a low regurgitation rate, but also reduces the frequency of pacemaker implantation thanks to Depth Guard technology.

Transcatheter aortic valve prosthetics. Boston Scientific destroys Medtronic and Edwards duopoly

Company representatives note that bringing the Lotus Edge valve system to market will provide a safe and effective alternative to treatment for patients with contraindications to traditional surgery. The new technology is a fundamental component of Boston Scientific's expanding portfolio. The company plans to begin a controlled release of the device in May 2019.

The company has repeatedly had to postpone the release of the Lotus Edge valve system in Europe, including due to lawsuits with competing companies. In February 2017, Boston Scientific recalled all Lotus type valves from the market due to reports of a mechanical failure in the operation of the pin connecting the valve to the delivery system. For several months, it was even rumored that Boston Scientific would abandon further development of Lotus Edge and instead focus on Acurate, an artificial valve inherited from Symetis. However, Boston Scientific executives quickly refuted these speculations.^[2]

2016: Recall of defective heart valves

At the end of October 2016, it became known that Boston Scientific asked its European customers to suspend operations to implant the new generation Lotus Edge heart valve due to possible problems in the device.

Boston Scientific recalls heart valves in Europe

According to the analyst of Barclays Matthew Taylor, in Europe about 200 operations on transcatheter prosthetics of the aortal Lotus Edge valve were performed. In 4% of cases, there were "some problems with the valve locking mechanism," after which a new device was installed, which was not accompanied by serious side effects, Taylor said in a note to investors. Boston Scientific confirmed the site MassDevice.com equipment malfunction and subsequent recall:

Boston Scientific initiates voluntary recall of Lotus Edge heart valve. During initial deliveries to a small number of European institutions, we received reports that in some cases the device cannot be fully fixed, which prevents the completion of the implantation procedure. In all cases, patients were successfully treated with a new valve.

At the same time, the manufacturer claims that the problem does not concern patients who have already implanted devices. As of the end of October 2016, Boston Scientific is completing an inspection of its products to find out the cause of the defect, and recommends that its customers use previous generation Lotus heart valves, which are still available in the European market.

Matthew Taylor says that the marriage found in Lotus Edge is unlikely to require constructive changes to the heart valve, nor will it affect Boston Scientific's revenue forecasts and change the timing of Lotus Edge's release in the United States.^[3]

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