St.Jude’s Endosense Acquisition Makes Sense

Earlier this year we covered the publication of contact-force guidelines when performing ablation surgery for paroxysmal atrial fibrillation. Most especially we focused on Endosense and its clever sensing technology which can demonstrably measure both contact force and force-time-integral, tapping right into the new guidelines. Now, like night follows day, the company has been snapped up by one of the big boys. In this case it’s St.Jude Medical, Inc. , which today announced the acquisition of the Swiss-based outfit. The acquisition adds to St.Jude’s electrophysiology portfolio and provides a robust platform for future product development.

Background

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 AF 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.

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 AF recurrence when contact force was used.

St. Jude Medical has made an initial payment of approximately 159 million Swiss francs ($170 million USD) and acquired 100 percent 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 ($161 million USD), which is contingent upon both the achievement and timing of a regulatory milestone.

St.Jude says the acquisition of Endosense is highly complementary to its business, providing 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.

Physician comments

“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 Dr. Vivek Reddy, professor of medicine and principal investigator in the TOCCASTAR trial at Mount Sinai Hospital, N.Y. “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.”

“TactiCath offers important improvements over previous-generation ablation catheters,” said Prof. Dr. 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.”

Company comments

“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 $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 U.S. markets, and has potential future applications across other St. Jude Medical technology platforms as well.”

Regulatory status

TactiCath is CE Mark approved for atrial fibrillation (AF) and supra ventricular tachycardia (SVT) ablation. In addition, Endosense just completed its U.S. IDE trial – the TOCCASTAR trial – and plans to submit its pre-market approval application to the U.S. Food and Drug Administration (FDA) in support of a paroxysmal AF indication before the end of 2013.

Source: St.Jude Medical, Inc., Business Wire