Feature | October 29, 2014

Abbott Expands Into Electrophysiology Market With Two Company Acquisitions

Abbott enters growing catheter-based EP market with next-generation technologies to improve treatment of atrial fibrillation

Topera, Abbott, FIRMap, rotors, rotor mapping

Topera's FIRMap diagnostic catheter produces dynamic electrical maps to identify rotors, the specific areas within the heart acting as a sustaining mechanism for atrial fibrillation.

Topera, Abbott, FIRMap, rotors, rotor mapping

An EP points out a rotor shown on Topera's rotor mapping system during an AF ablation procedure.

Topera, Abbott, FIRMap, rotors, rotor mapping

Topera's rotor mapping system screen, showing a rotor origin, shown in blue, around which the electrical signals for AF rotate.

Oct. 29, 2014 – Abbott has entered into an agreement to purchase Topera Inc., a private, venture-backed medical device company focused on developing electrophysiology technologies to improve the diagnosis and treatment of atrial fibrillation (AF). Through this acquisition, Abbott enters the catheter-based electrophysiology (EP) market, an approximately $3 billion global market that has been growing annually at double-digit rates.
 
Topera has developed a novel diagnostic catheter and mapping software to identify electrical rotors associoated with the source of AF. This helps physicians identify and target the specific areas of a person's heart that are perpetuating atrial fibrillation. Under the terms of the acquisition, Abbott will acquire all outstanding equity of Topera for $250 million upfront, plus potential future payments tied to performance milestones.
 
Topera's rotor identification system has been shown, when used with existing catheter ablation therapy, to result in positive long-term success rates, even in difficult-to-treat cases. According to an independent, multi-center, physician-sponsored study, using Topera's system with catheter ablation resulted in a single-procedure success rate of 87.5 percent in patients undergoing a first ablation procedure, and an 80.5 percent success rate for all patients after a one-year follow-up.[1] This compares to only a 50 to 60 percent success rate for patients treated with existing catheter ablation therapy alone.[2] During ablation procedures a catheter is placed in a specific area of the heart, where it uses energy to disrupt the abnormal electrical activity linked to atrial fibrillation. In addition to improving long-term outcomes with fewer procedures, using Topera's rotor mapping system may result in shorter ablation times for some procedures because it identifies and targets the specific areas in an individual patient's heart that are perpetuating the irregular heartbeats.[3]
  
In a separate transaction in the electrophysiology market, Abbott has secured the right to purchase Advanced Cardiac Therapeutics Inc. (ACT) in the future, upon completion of key milestones. ACT, a private, venture-backed company, is developing a novel ablation catheter designed to improve the safety and effectiveness of ablation procedures. Financial terms were not disclosed.
 
"There is significant room to use advanced rotor identification technologies to improve the success rate and reduce the need for multiple ablation procedures, and thus improve the health of people with atrial fibrillation," said John M. Capek, Ph.D., executive vice president, medical devices, Abbott. "The Topera acquisition and our agreement with ACT provide a foundational entry into the large, high-growth electrophysiology market, with differentiated technologies that can transform the way physicians treat people with complex heart rhythm disorders."
 
"Topera's mapping technology has the potential to change the paradigm for how physicians approach treating people with atrial fibrillation," said John Miller, M.D., professor of medicine and director of clinical cardiac electrophysiology at Indiana University Health. "The ability to more accurately target the areas of the heart perpetuating atrial fibrillation is a significant advancement in the field of electrophysiology, which may allow us to treat more people with atrial fibrillation and lead to better health results." 
 
Abbott's electrophysiology business will be led by industry veteran Michael Pederson, who joins Abbott from VytronUS Inc., a privately held medical device company, where he was president and chief executive officer.  
 
Topera Rotor Identification System
The Topera rotor identification system transforms current catheter ablation approaches, which primarily rely on a one-size-fits-all anatomical approach, by providing a tailored treatment for each patient's specific and unique physiology. Initially, the Topera System may supplement current procedures, but with more clinical evidence Topera's patient-focused approach could become the primary procedure for patients with atrial fibrillation.
 
The Topera System, which consists of the RhythmView workstation and the FIRMap diagnostic catheter, produces information that is designed to allow physicians to identify and locate rotors, the specific areas within the heart acting as a sustaining mechanism for atrial fibrillation. The technology allows physicians with special training in the electrical system of the heart, called electrophysiologists, to see individual patient-specific rotors, which leads to more accurate diagnosis and effective treatment.
 
Topera's RhythmView workstation and FIRMap diagnostic catheter received U.S. Food and Drug Administration clearance and CE mark in Europe in 2013. 
 
ACT Ablation Catheter
ACT's TempaSure catheter uses enhanced sensing technology to help physicians ensure they have achieved safe and effective ablation. The catheter has the ability to sense tissue temperature at depth, which is significant because it allows physicians to deliver the correct dosage of energy to achieve effective ablation while ensuring the safety of the procedure.
 
The Transactions
Completion of the Topera acquisition is subject to customary closing conditions, including antitrust clearance.  It is expected to close in the fourth quarter of this year. Neither the Topera acquisition nor the right to purchase ACT is expected to impact Abbott's ongoing full-year 2014 earnings-per-share guidance. Topera is headquartered in Menlo Park, Calif., and ACT is headquartered in Santa Clara, Calif.
?
For more information: www.abbott.com
?
References: 
1. Miller J, Kowal R, Swarup V, et al. Initial Independent Outcomes from Focal Impulse and Rotor Modulation Ablation for Atrial Fibrillation. Cardiovasc Electrophysiol. 2014 Sep; 25(9):921-9. doi: 10.1111/jce.12474. Epub 2014 Jul 23.
 
2. Calkins H, Reynolds M, Spector P, et al. Treatment of Atrial Fibrillation with Antiarrhythmic drugs or radiofrequency ablation: Two systematic literature reviews and meta-analyses. Circulation. 2009, 2:349-361.
 
3. Narayan SM, et al. Treatment of atrial fibrillation by the ablation of localized sources: The Conventional Ablation for AF With or Without Focal Impulse and Rotor Modulation (CONFIRM) Trial. JACC 2012 60(7)628-636.
 
4. Chugh S, Havmoeller R, Narayanan K, et al. Worldwide Epidemiology of Atrial Fibrillation: A Global Burden of Disease 2010 Study. Circulation 2014;129:837-847. 
 

Related Content

Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
Technavio Projects 9 Percent Global Growth for Electrophysiology Therapeutic Devices

Image courtesy of Technavio

News | EP Lab| September 11, 2017
September 11, 2017 — According to the latest market study released by Technavio, the global...
LAA closure during open heart surgery in the LAACS Study showed better outcomes for all patients.

LAA closure during open heart surgery in the LAACS Study showed better outcomes for all patients.

Feature | Left Atrial Appendage (LAA) Occluders| September 07, 2017
September 7, 2017 — Closure of the left atrial appendage (LAA) during heart surgery protects the brain, according to
EMANATE Trial Shows Apixaban Lowers stroke in AF Patients Undergoing Cardioversion.
News | Atrial Fibrillation| September 01, 2017
September 1, 2017 — Apixaban lowers the risk of stroke compared to warfarin in anticoagulation-naïve patients with at
CASTLE-AF Study shows Catheter Ablation of Atrial Fibrillation is First-Line Treatment for Heart Failure Patients. Biotronic Ilivia 7 ICD.

The CASTLE-AF Study shows catheter alation of AF can be used effectively to treat heart failure in patients with an implanted ICD.

News | Atrial Fibrillation| September 01, 2017
September 1, 2017 — Final results from the CASTLE-AF study show a 38 percent reduction in the composite of all-cause
Abbott. St. Jude Medical has updated its firmware to address cybersecurity issues with its Allure Quadra MP and other EP devices

Abbott. St. Jude Medical has updated its firmware to address cybersecurity issues with its Allure Quadra MP and other EP devices.

Feature | EP Lab| August 29, 2017 | Dave Fornell
August 29, 2017 — The U.S.
Real-World Analysis Compares Safety, Effectiveness of Apixaban Versus Warfarin
News | Antiplatelet and Anticoagulation Therapies| August 28, 2017
August 28, 2017 — Bristol-Myers Squibb Company and Pfizer Inc.
Biotronik Announces U.S. Launch of Edora HF-T QP CRT Pacemaker
Technology | Cardiac Resynchronization Therapy Devices (CRT)| August 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and commercial availability of Edora HF-T QP, an...
The FDA is concerned about cybersecurity of ICDs and cyber security of other medical devices.
Feature | Cybersecurity| August 16, 2017 | Dave Fornell
There is growing concern among patients and regulators that medical devices, especially implantable electrophysiology
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Overlay Init