What is the LOTUS Edge™ Aortic Valve System?

The LOTUS Edge™ Aortic Valve System is a transcatheter aortic valve replacement (TAVR) device designed to treat patients with severe aortic stenosis who are at high or extreme risk for open-heart surgery. It is delivered via a catheter-based procedure, avoiding the need for major open-heart surgery.

What is a Premarket Approval (PMA) application?

A Premarket Approval (PMA) application is the FDA's process for evaluating the safety and effectiveness of Class III medical devices. It is the most stringent type of medical device submission, requiring extensive scientific and clinical data.

What is the significance of submitting the final technical module?

Submitting the final technical module signifies that Boston Scientific believes it has compiled all necessary technical and scientific evidence to support the safety and efficacy of the LOTUS Edge™ Aortic Valve System for FDA review. It is a critical step towards potential market approval in the United States.

What should investors look for next?

Investors should closely follow updates from Boston Scientific and the FDA regarding the review process of the LOTUS Edge™ PMA. Key developments to monitor include the FDA's decision timeline, any requests for additional information, and ultimately, the FDA's approval or denial of the application.

BSX 8-K: Regulation FD

Summary

Boston Scientific Corporation (BSX) has announced a significant step forward for its LOTUS Edge™ Aortic Valve System. The company plans to submit the final technical module of its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) during the week of August 13, 2018. This submission is a crucial milestone in the regulatory process for this novel transcatheter aortic valve replacement (TAVR) device. Investors should monitor the FDA's review process and any subsequent updates regarding potential market approval.

Key Highlights

1BSX to submit final technical module of LOTUS Edge™ Aortic Valve System PMA application to FDA.
2Submission is scheduled for the week of August 13, 2018.
3The LOTUS Edge™ System is a transcatheter aortic valve replacement (TAVR) device.
4This submission represents a key step in the regulatory approval process.
5Investors should track the FDA's review and potential approval timeline.

BOSTON SCIENTIFIC CORP 8-K Report, Regulation FD Disclosure (Aug 8, 2018)

Summary

Key Highlights

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