Mitral Valve Repair Global Leader: Edwards LifeSciences acquired Harpoon Medical for $250 in 12/2017 followed by $690 million buyout of Valtech Cardio 1/2017 and $400 million acquisition of CardiAQ Valve Technologies in 8/2016
Reporter: Aviva Lev-Ari, PhD
UPDATED on 3/25
Edwards Prevails In U.S. Patent Office Review That Finds Boston Scientific Transcatheter Valve Patent Claims Invalid
WASHINGTON, March 23, 2018 — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that the United States Patent and Trademark Office (USPTO) decided in Edwards’ favor in an Inter Partes Review (IPR) of Boston Scientific’s U.S. transcatheter heart valve patent, number 8,992,608 (the ‘608 patent). The USPTO determined that all claims of the ‘608 patent that have been asserted against Edwards are invalid.
The ‘608 patent was asserted against Edwards in a case filed by Boston Scientific in Delaware in 2016. Subsequently, Edwards asserted three of its own foundational transcatheter heart valve patents against Boston Scientific. The Edwards patent claims are unaffected by the USPTO’s ruling and will continue to trial, which is expected later in 2018.
Acquisitions of small players marks the ENTRY of Edwards LifeSciences into the Mitral Valve Repair Market, following MAJOR success in TAVR.
- Harpoon Medical (trans apical approach) in 12/2017 and
- CardiAQ Valve Technologies in 8/2016
- $690 million buyout of Valtech Cardio, 1/2017 – It does not include Valtech Cardio’s trans-septal mitral valve replacement program; that business is slated to be spun out on its own before the buyout’s closing, expected in early 2017, but Edwards said last year that it’s due to keep an option to buy.
Edwards buys mitral valve repair player in $250M deal – Harpoon Medical
“The unique beating-heart repair procedure for mitral valve patients complements Edwards’ comprehensive portfolio of treatments for structural heart disease, and reinforces our commitment to innovation in cardiac surgery.”
The HARPOON system is designed to facilitate echo-guided repair of mitral valve regurgitation, by stabilizing the prolapsed mitral valve leaflet to restore proper coaptation and valve function. The HARPOON device is currently investigational and not available for commercial use. It is expected to receive CE Mark approval soon.
“There are a significant number of patients currently undergoing mitral valve surgery that we believe can benefit from Harpoon’s therapy during a minimally invasive, beating-heart procedure,” said device inventor James S. Gammie, M.D., chairman of the company’s scientific advisory board and professor and chief of cardiac surgery at the University of Maryland School of Medicine. “This therapy offers the potential for earlier treatment of degenerative mitral valve disease with faster recovery and less morbidity, while also providing the opportunity for more consistent procedures and outcomes for patients.”
Edwards will discuss the HARPOON technology further at its annual Investor Conference on Dec. 7.
Edwards Lifesciences closes $690m Valtech Cardio buy
Edwards Lifesciences (NYSE:EW) said yesterday that it closed the $690 million buyout of Valtech Cardio and most of the heart valve repair technologies it’s developing.
Valtech makes the Cardioband device, which is designed to reshape the mitral valve using specially designed anchors.
The deal, announced in November 2016, calls for $340 million in up-front cash and another $350 million in milestones over 10 years. It does not include Valtech Cardio’s trans-septal mitral valve replacement program; that business is slated to be spun out on its own before the buyout’s closing, expected in early 2017, but Edwards said last year that it’s due to keep an option to buy.
Or Yehuda, Israel-based Valtech was the target of a previous takeover attempt by HeartWare International that was spiked early this year after a proxy war. (HeartWare itself was acquired by Medtronic (NYSE:MDT) for $1.1 billion in August.) Valtech won CE Mark approval in the European Union for Cardioband in September 2015 but the device is not approved for the U.S. market.
“We look forward to the Valtech team joining Edwards. We believe their knowledge, experience and the Cardioband technology are valuable additions to Edwards,” Edwards chairman & CEO Michael Mussallem said in prepared remarks.
Edwards Lifesciences bought CardiAQ Valve Technologies and its mitral valve device for $400 million last August.
Shares in Edwards have plummeted today in mid-day trading, down 9.1% at $89.06 as of 12:45 p.m. EST.
Last month, Edwards said it closed the $690 million buyout of Valtech Cardio and most of the heart valve repair technologies it’s developing.
Valtech makes the Cardioband device, which is designed to reshape the mitral valve using specially designed anchors.
The deal, announced in November 2016, calls for $340 million in up-front cash and another $350 million in milestones over 10 years. It does not include Valtech Cardio’s trans-septal mitral valve replacement program; that business is slated to be spun out on its own before the buyout’s closing, expected in early 2017, but Edwards said last year that it’s due to keep an option to buy.
SOURCE
http://www.massdevice.com/edwards-pauses-cardiaq-valve-clinical-trial-enrollment/
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