Edwards Lifesciences (NYSE:EW) last month recalled the anchors used with its Cardioband mitral valve repair device after receiving a pair of reports that the device came loose from the surrounding tissue.
The Cardioband device, acquired in the $690 million buyout of Valtech Cardio last year, is designed to reshape the mitral valve using specially designed anchors. In a letter to physicians posted by German regulators Jan. 26, Edwards said a manufacturing tweak, although within its specs, was responsible for the issue.
“Through the review of recent case reports, we have noted an increased number and rate of Cardioband anchor disengagement events, both during and in the days after mitral implantation,” according to the letter from quality affairs VP Mark Gayle. “Such anchor disengagements have led, in up to two cases, to Cardioband implant dehiscence requiring intervention.
“Many patients treated with the Cardioband to date are in clinical trials; we recommend following up those patients per their trial protocols. For patients treated outside a clinical study protocol and treated between July and December 2017, we recommend you consider echocardiographic follow‐up between 3 – 6 months after implant, or sooner if symptoms warrant,” Gayle wrote.
An Edwards spokeswoman told MassDevice.com via email today that the company decided to “tighten” the manufacturing process for Cardioband as part of its integration into Irvine, Calif.-based Edwards.
“We expect to replenish inventories and resume treatment of patients in March,” she wrote.
The recalled anchors, which were not implicated in any deaths, pose no risk of embolization because they remain attached to the implant, Gayle wrote. The recall affects only the anchors, not the band or delivery system, the spokeswoman told us.
Edwards closed the Valtech buy in January 2017, paying $340 million in up-front cash and pedging another $350 million in milestones over 10 years. The deal did not include Valtech’s trans-septal mitral valve replacement program; that business was slated to be spun out on its own before the buyout’s closing with Edwards keeping 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 2016.) Valtech won CE Mark approval in the European Union for Cardioband in September 2015; it is not approved for the U.S. market.
