Feature | Heart Valve Technology | November 17, 2020| Dave Fornell, Editor

Boston Scientific Pulls Lotus Edge TAVR Valve Off The Market

The company has initiated a voluntary recall of the Lotus Edge transcatheter aortic valve system and will refocus TAVR efforts on its Acurate Neo2 valve

oston Scientific Corp. announced today it is immediately retiring the entire Lotus Edge transcatheter aortic valve replacement (TAVR) system. It also initiated a global, voluntary recall of all unused inventory of the Lotus Edge due to complexities associated with the product delivery system. 

November 17, 2020 — Boston Scientific Corp. announced today it is immediately retiring the entire Lotus Edge transcatheter aortic valve replacement (TAVR) system. It also initiated a global, voluntary recall of all unused inventory of the Lotus Edge due to complexities associated with the product delivery system. 

The company said the recall is related solely to the delivery system, as the valve continues to achieve positive and clinically effective performance post-implant. Boston Scientific said there is no safety issue for patients who currently have an implanted Lotus Edge valve.

Given the additional time and investment required to develop and reintroduce an enhanced delivery system, the company has chosen to discontinue the entire Lotus product platform rather than spending additional resources on a new delivery platform. All related commercial, clinical, research and development and manufacturing activities will also cease.

"While we have been pleased with the benefits the Lotus Edge valve has provided to patients, we have been increasingly challenged by the intricacies of the delivery system required to allow physicians to fully reposition and recapture the valve," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "The complexity of the delivery system, manufacturing challenges, the continued need for further technical enhancements, and current market adoption rates led us to the difficult decision to stop investing in the Lotus Edge platform. We will instead focus our resources and efforts on our Acurate neo2 Aortic Valve System, Sentinel Cerebral Embolic Protection System and other high growth areas across our portfolio."

 

The Boston Scientific Sentinal and Acurate Neo2 TAVR valve

Boston Scientific said it will concentrate development efforts on its Acurate neo2 next generation TAVR valve system and the Sentinel Cerebral Embolic Protection System designed to help lower strokes caused by TAVR procedures.

 

Lotus was the Third TAVR Valve to Gain FDA Clearance But Lacked Wider Patient Use Indications

The U.S. Food and Drug Administration (FDA) cleared the Lotus Edge in April 2019, and it became the third TAVR valve to enter the U.S. market. 

However, being a late-comer to the market it did not have the same level of clinical experience as its computers, the Edwards Lifesciences Sapien 3 and the Medtronic CoreValve Evolut. While Lotus was just starting to find its way into U.S. hospitals in the summer of 2019 with an indication only for high-risk patients with severe, symptomatic aortic stenosis, CoreValve and Sapien both gained a new indication in August 2019 that expanded their use to low-risk patients. They already had indications for intermediate risk patients as well. The move effectively allows the use of these two TAVR valves in all patients with severe, symptomatic aortic stenosis.

Boston Scientific said the Lotus was designed to offer improved TAVR outcomes over Sapien and CoreValve. The biggest point of difference is that it was the only FDA-cleared aortic valve that gives physicians the option to reposition and completely recapture the valve once it has been fully deployed. It also featured a braided wire valve frame and an adaptive seal that minimizes paravalvular regurgitation or leaking (PVL) by conforming to the patient's native aortic valve.

However, operator experience with CoreValve and Sapien at high TAVR volume centers has greatly improved in recent years and been shown in clinical trials to offer better outcomes than the previous gold standard of surgical valve replacement (SAVR). While Lotus offered promising new technology, the existing valves were already entrenched in U.S. structural heart programs and offered more clinical experience and data than Lotus. Operators were also familiar with the Sapien and CoreValve delivery systems, which had gone through revisions to improve their performance.

According to the healthcare market research firm GlobalData, in 2019, once the device became commercially available, the company was able to capture a small amount of U.S. TAVR market share, about 1.5 percen. The company said this led to revenue of just under $30 million for the company in the U.S. alone. In the first three quarters of 2020, Boston Scientific’s U.S. TAVR market share grew to 2.24 percent, bringing with it increased revenue, even in the face of the COVID-19 pandemic, according to GlobalData.

“However, the Lotus Edge device has faced issues in the past. In 2017, while the device was commercially available in Europe, Boston Scientific issued a voluntary recall over issues to do with its delivery system and locking mechanism," GlobalData said in a statment about the Lotus being pulled off the market. "The device returned to market later in the same year. However, Boston Scientific has indicated that the current global recall is permanent, with no plans to return the Lotus device to market."

Business Impact of No longer Selling the Lotus TAVR Valve Off the Market

This decision stop sales of the Lotus TAVR valve is expected to result in estimated total pre-tax generally accepted accounting principles (GAAP) charges of approximately $225 million to $300 million due to inventory, fixed asset, intangible asset and certain other exit charges, and approximately $100 million to $150 million of these charges will impact the company's adjusted results. The vast majority of these charges will be recorded during the fourth quarter of 2020. The decision is expected to be accretive to GAAP and adjusted earnings per share in 2021 by approximately one to two cents and neutral thereafter.

For more information: www.bostonscientific.com 

 

Related TAVR Content:

VIDEO: Tracking Transcatheter Valve Outcomes in the STS-ACC TVT Registry — Interview with John Carroll, M.D.

Boston Scientific Receives FDA Approval for Lotus Edge Aortic Valve System

FDA Approves TAVR for Low-risk Patients Creates A Paradigm Shift in Cardiology

TAVR Expected to See Rapid Growth in Next 5 years

Boston Scientific Launches Acurate neo2 Transcatheter Aortic Valve System in Europe

Acurate neo TAVR Valve Fails to Meet Noninferiority With Medtronic CoreValve Evolut

VIDEO: Interventional Structural Heart Advances Are Rapidly Expanding — Interview with Juan F. Granada, M.D.

Boston Scientific Launches Acurate neo2 Transcatheter Aortic Valve System in Europe

TAVR Non-Inferior to Surgery in U.K. Review of Surgery vs. TAVR

U.S. TAVR Outcomes Need Improvement Based on TVT Registry Analysis

 

 

 

 

Related Content

Image from the announcement of the Neal award winner of best technical content for DAIC's coverage of COVID-10 related to cardiology at the Neal virtual award ceremony June 9.

Image from the announcement of the Neal award winner of best technical content for DAIC's coverage of COVID-10 related to cardiology at the Neal virtual award ceremony June 9.

Feature | Cardiovascular Business | June 10, 2021
Avoiding high-risk PCI procedures does not improve hospital scores according to a study presented at SCAI 2021. CTO procedure at Henry Ford Hospital, Detroit. Photo by Dave Fornell.

Avoiding high-risk PCI procedures does not improve hospital scores according to a study presented at SCAI 2021. CTO procedure at Henry Ford Hospital, Detroit. Photo by Dave Fornell.

News | Cardiovascular Business | May 05, 2021
May 5, 2021 — A late-breaking study presented at the...
Cardinal Health Sells its Cordis Cardiology Business to Hellman & Friedman. Hopes to build the Cordis Accelerator for innovative cardiovascular device development.
News | Cardiovascular Business | March 12, 2021
March 12, 2021 — Cardinal Health today announced that it is selling its...
An interventional radiologist consults with a patient in an out patient cath lab at a Modern Vascular clinic. The company is building several out patient clinics to capture a share of the interventional market for peripheral artery disease (PAD) catheter-based therapies. 

An interventional radiologist consults with a patient in an out patient cath lab at a Modern Vascular clinic. The company is building several out patient clinics to capture a share of the interventional market for peripheral artery disease (PAD) catheter-based therapies. 

News | Cardiovascular Business | February 03, 2021
February 3, 2021 — Modern Vascular is a medical group that has 13 outpatient cath lab clinics to treat...
COVID-19 cardiology related content continues to be among the top performers on the DAIC website in November 2020. TAVR also topped headlines with Boston Scientific taking its Lotus valve off the market and a review of TAVR registry data showing it is now the dominant method of aortic valve replacement in the United States. #DAIC

COVID-19 cardiology related content continues to be among the top performers on the DAIC website in November 2020. TAVR also topped headlines with Boston Scientific taking its Lotus valve off the market and a review of TAVR registry data showing it is now the dominant method of aortic valve replacement in the United States.

Feature | Cardiovascular Business | December 01, 2020 | Dave Fornell, Editor
December 1, 2020 — Here is the list of the most popular content on the Diagnostic and Interventional Cardiology (DAIC
Survey data showing opinions of physicians and hospital administrators on barriers to implementing new technology and how new technologies have improved cardiovascular care.

Survey data showing opinions of physicians and hospital administrators on barriers to implementing new technology and how new technologies have improved cardiovascular care.

News | Cardiovascular Business | September 14, 2020
September 14, 2020 — New global research released by Abbott takes a deep dive into the barriers of cardiovascular pat
Philips angiography system in a cath lab at Henry Ford Hospital.
Feature | Cardiovascular Business | July 13, 2020 | Deb Thompson and Christian Comeau
For a cardiovascular service line leader, addressing challenges in an evolving healthcare climate is a constant.
Leeds Hospital recently installed Philips Azurion angiography interventional labs to enhance procedural guidance capabilities.

Leeds Hospital recently installed Philips Azurion angiography interventional labs to enhance procedural guidance capabilities.

News | Cardiovascular Business | July 08, 2020
July 8, 2020 – Philips Healthcare and Leeds Teaching Hospitals NHS Trust announced a seven-year managed service agree