The concept of the leadless Implantable Cardioverter Defibrillator(ICD) is very much “of the moment”, given the amount of coverage big guns Medtronic and St Jude have been receiving for problems associated with lead “externalisation” in their respective offerings. Boston Scientific’s move to exercise its option to acquire Californian company Cameron Health, Inc.is not therefore too surprising as it has developed the world’s first and only commercially available subcutaneous implantable cardioverter defibrillator – the S-ICD® System.
Unlike conventional ICDs, which require insulated 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. This one-of-a-kind technology has the potential to expand the reach of ICD therapy, offering physicians and appropriate patients a new alternative to traditional ICDs, while strengthening Boston Scientific’s arrhythmia management portfolio.
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 PMA application to the U.S. Food and Drug Administration (FDA) in December 2011. Boston Scientific anticipates FDA approval for the S-ICD System in the first half of 2013.
The deal which speaks of potential
The agreement comprises an initial payment of $150 million, payable upon transaction closing, an additional potential $150 million payment upon FDA approval of the S-ICD System. There is then an additional $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 represents a new category of rhythm management devices that is unlike anything available today,” said Kenneth A. Ellenbogen, M.D., F.A.C.C., Professor of Medicine and Director of the Electrophysiology Laboratory at the Medical College of Virginia. “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.”
Hank Kucheman, Chief Executive Officer of Boston Scientific said; “We believe that the S-ICD System represents a breakthrough treatment for patients at risk of sudden cardiac arrest and strengthens our ability to deliver value to physicians, their patients and healthcare systems around the world.”
For Cameron Health, Kevin Hykes, President and CEO stated “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. We look forward to joining the Boston Scientific team, which will allow us to expand our commercialization efforts and bring this proven therapy to more patients around the world.”
Source: Boston Scientific