LivaNova to drop TMVR plans in global heart valve restructuring

LivaNova announced plans to restructure its heart valve operations, and that it will drop its investigational Caisson transcatheter mitral valve replacement program altogether.

Though its valve business segment brought in $130 million in revenue over 2018, it has been seeing declines over the past five years, in both its biological and mechanical offerings, according to LivaNova. 

Combined with competitive market conditions and rising costs in maintaining its portfolio, the London-based company said it will be reorganizing its various international divisions.

“We will restructure and simplify our heart valve manufacturing network, which will eliminate operational overlap between facilities and enable us to address new regulatory requirements,” CEO Damien McDonald said in a statement. LivaNova’s stock price on the Nasdaq mostly held steady around $79, despite some initial wobbles following the news.

RELATED: LivaNova strikes $250M deal to buy TandemLife

The Caisson three-flap mitral
valve replacement and anchor
system (LivaNova)

Going forward, the company’s facility in Saluggia, Italy will be dedicated to R&D and production of mechanical heart valves, rings, accessories and nitinol stents. Meanwhile, tissue heart valve production will be concentrated at the company’s plant in Vancouver, Canada.

Caisson’s operations, centered in Minneapolis, Minnesota, will be closed at the end of the year. LivaNova said it expects about 150 employees to be impacted across all three sites. 

Patients in Caisson clinical trials will continue to be followed. The minimally invasive procedure aimed to use a catheter and anchor placement to replace a patient’s failing, bicuspid mitral valve with an artificial tricuspid valve, to treat regurgitation. The device was acquired through LivaNova’s $72 million acquisition of its designer, Caisson Interventional, in 2017.