Boston Scientific acquires world’s first subcutaneous ICD


Device company Boston Scientific has closed its acquisition of Cameron Health and, as a result, added to its product portfolio the world’s first and only commercially available subcutaneous implantable cardioverter defibrillator (ICD), called the S-ICD system.

The acquisition is the capstone of a nearly 10-year relationship between the two companies during which Boston Scientific invested in Cameron Health during its ground-breaking research and product commercialisation efforts.

Developed by Cameron Health, the entire S-ICD System sits just below the skin.This leaves the heart and blood vessels untouched, offering patients an alternative to conventional transvenous ICDs, which require thin, insulated leads to be placed into the heart itself.

Hank Kucheman, chief executive officer at Boston Scientific, said: “We are pleased to complete the acquisition of Cameron Health, furthering Boston Scientific’s commitment to introducing innovation in the cardiac rhythm management space. Boston Scientific now provides physicians and their patients with an option to choose either the industry’s thinnest, longest-lasting transvenous ICD or the world’s first and only commercially available completely subcutaneous ICD.”

Kevin Hykes, former chief executive officer of Cameron Health, said: “We believe that the combination of Cameron Health’s breakthrough technology and Boston Scientific’s already strong arrhythmia management product portfolio and commercial capabilities will help unlock the enormous potential of the S-ICD System.” Hykes will continue to lead the S-ICD team at Boston Scientific. He added: “Equally exciting is the promise of next-generation subcutaneous technology that we expect will continue to expand the reach of ICD therapy to more patients.”

At the recent Heart Rhythm Society’s 33rd Annual Scientific Sessions in Boston, Cameron Health announced initial results from the international “Evaluation of Factors Impacting Clinical Outcome and Cost Effectiveness (EFFORTLESS) Subcutaneous Implantable Defibrillator Registry” study that showed the S-ICD System is performing appropriately in real-world circumstances and continues to demonstrate positive results in a study of 230 patients.

Cameron Health also announced at the conference that the S-ICD System met the primary safety and efficacy endpoints defined in their 330-patient IDE clinical study (see Subcutaneous defibrillator is safe and effective).
The patient population in the IDE study patient population closely mirrored real world populations with transvenous ICDs, demonstrating that the S-ICD System is an important new treatment option for a wide range of primary and secondary prevention patients.

The transaction between Cameron Health and Boston Scientific follows Boston Scientific’s exercise of its option to acquire Cameron Health, which was announced on March 8, 2012. Under the terms of the agreement, Boston Scientific paid $150 million at closing. The agreement calls for an additional potential payment of $150 million to be made upon FDA approval of the S-ICD System and up to an additional $1.050 billion of potential payments to be made upon the achievement of specified revenue-based criteria over a six-year period following FDA approval.The company currently expects the transaction to be approximately $0.01 dilutive in 2012 and approximately break-even in 2013 to earnings per share on an adjusted basis and more dilutive in both years on a GAAP basis as a result of acquisition-related net charges and amortization, which will be determined following the closing.

The S-ICD System is an investigational device and limited under US law to investigational use only, and is not available for sale in the US.