St Jude Medical has made an initial payment of approximately 159 million Swiss Francs (US$170 million) and acquired 100% of the outstanding equity of Endosense. The terms of the transaction also provide for an additional cash payment of up to 150 million Swiss Francs (US$161 million), which is contingent upon both the achievement and timing of a regulatory milestone.
The company funded the initial payment using available cash from outside of the USA and expects to make any future payments using these same cash balances. Except for acquisition-related expenses, this acquisition does not impact St Jude Medical’s outlook for 2013 consolidated earnings per share, according to a press release.
Endosense force-sensing technology
Endosense developed the TactiCath irrigated ablation catheter to give physicians a real-time, objective measure of the force they apply to the heart wall during a catheter ablation procedure. Without contact-force data, physicians have to estimate the amount of force applied to the heart wall during an ablation. If too little force is applied, there is a risk of incomplete lesion formation that could result in atrial fibrillation recurrence, potentially requiring additional treatments. If too much force is applied, there is a risk of tissue injury, which can lead to serious procedure-related complications.
“Force sensing is a tremendous advancement in cardiac ablation that will potentially improve safety and efficacy, likely becoming a standard for all cardiac ablations,” said Vivek Reddy, professor of medicine and principal investigator in the TOCCASTAR trial at Mount Sinai Hospital, New York, USA. “As the first and most studied force-sensing catheter on the market, TactiCath now provides St Jude Medical with a best-in-class ablation catheter.”
There is a growing body of evidence to support the safety and effectiveness of contact-force ablation technology, including Endosense’s TOCCATA, EFFICAS I and EFFICAS II studies, which have collectively demonstrated safety and reduced rate of atrial fibrillation recurrence when contact force was used. TactiCath is CE mark approved for atrial fibrillation and supra ventricular tachycardia (SVT) ablation. In addition, Endosense just completed its US IDE trial-the TOCCASTAR trial-and plans to submit its pre-market approval application to the US Food and Drug Administration (FDA) in support of a paroxysmal atrial fibrillation indication before the end of 2013.
“TactiCath offers important improvements over previous-generation ablation catheters,” said Karl-Heinz Kuck, director of cardiology at St Georg Hospital in Hamburg, Germany. “While low contact force can lead to ineffective lesions, excessive contact force can cause safety concerns. The ability to more precisely measure this force improves procedural efficiency and provides increased confidence that an ablation will be effective in treating complex cardiac arrhythmias.”
The acquisition of Endosense is highly complementary to the St Jude Medical business, according to a press release. The Endosense force-sensing technology provides a strong, patent-protected platform for future product development. Immediate opportunities to integrate this technology into other proprietary St Jude Medical technologies include the potential to offer a MediGuide-enabled force-sensing ablation catheter and to incorporate force sensing data into the company’s EnSite Velocity Mapping System. In addition, St Jude Medical’s global presence and geographic distribution scale can further strengthen and enhance Endosense’s international growth in a number of markets.
“The acquisition of Endosense further strengthens our industry-leading portfolio of products to treat patients with cardiac arrhythmias, and provides an opportunity to accelerate our market share capture in the US$900 million global cardiac ablation catheter market,” said Frank J Callaghan, president of the Cardiovascular and Ablation Technologies Division of St Jude Medical. “This transaction significantly accelerates our timeline to providing an irrigated ablation catheter that incorporates force sensing in both international and US markets, and has potential future applications across other St Jude Medical technology platforms as well.”