Boston Scientific has announced the exercise of its option to acquire Cameron Health which is the developer of the world’s first and only commercially available subcutaneous implantable cardioverter defibrillator – the S-ICD system.
The S-ICD system has received CE mark and has been commercially available in select geographies, including several major European countries, since 2009. The system has been clinically evaluated in a variety of studies and has been implanted in more than 1,000 patients worldwide. Cameron Health received expedited review status and submitted its premarket application to the FDA in December 2011. Boston Scientific anticipates FDA approval for the S-ICD system in the first half of 2013.
Unlike conventional implantable cardioverter defibrillators (ICDs), which require thin, insulated wires (leads) to pass through the venous system and into the heart, the entire S-ICD system sits just below the skin and leaves the heart and blood vessels untouched.
“With Cameron, we gain a strong, experienced team of professionals who are pioneers in this novel technology, and we are thrilled to welcome them to Boston Scientific,” said Hank Kucheman, CEO, Boston Scientific.
“The S-ICD system was designed to eliminate the complications associated with transvenous leads, creating an important new treatment option for patients at risk of sudden cardiac arrest,” said Kevin Hykes, president and CEO, Cameron Health. “We look forward to joining the Boston Scientific team, which will allow us to expand our commercialisation efforts and bring this proven therapy to more patients around the world.”
“The S-ICD system represents a new category of rhythm management devices that is unlike anything available today,” said Kenneth A Ellenbogen, professor of Medicine and director of the Electrophysiology Laboratory at the Medical College of Virginia, USA. “This system provides physicians with a new alternative in the treatment of patients at risk for sudden cardiac arrest and should become first-line therapy for patients who may benefit from not having a lead in the heart.”
The agreement calls for an upfront payment of US$150 million, payable upon transaction closing, an additional potential US$150 million payment upon FDA approval of the S-ICD system, plus up to an additional US$1.050 billion of potential payments upon achievement of specified revenue-based milestones over a six-year period following FDA approval.
The S-ICD system is restricted under Federal law for investigational use only and is not for sale in the USA.