News | Ablation Systems | October 02, 2017

Boston Scientific to Acquire EP Technology Company Apama Medical

Acquisition will strengthen company's electrophysiology portfolio and expand into single-shot balloon pulmonary vein isolation for atrial fibrillation

The Apama Radiofrequency (RF) Balloon Catheter System.

October 2, 2017 — Boston Scientific announced a definitive agreement to acquire Apama Medical Inc., a privately-held company that is developing the Apama Radiofrequency (RF) Balloon Catheter System for the treatment of atrial fibrillation (AF). The deal calls for $175 million in cash up-front and a maximum of $125 million in contingent payments over the period of 2018-2020, based on achievements of clinical and regulatory milestones.

AF, a common heart rhythm disorder estimated to affect more than 33 million people worldwide,[1] is commonly treated with anti-arrhythmic drugs as well as cardiac ablation – the process of delivering energy to the areas of the heart muscle causing an abnormal rhythm. The standard of care in AF ablations is pulmonary vein isolation (PVI) – the application of energy to create lines of scar tissue around the pulmonary veins in the left atrium to block unwanted electrical signals that trigger AF. PVI is currently performed using two different technologies: point-by-point RF-based ablation and single-shot balloon-based ablation.

The Apama RF balloon – a single-shot, multi-electrode technology – is designed to combine the primary benefits of both RF point-by-point and balloon-based ablation approaches, notably the ability to deliver differentiated levels of energy and shortened procedure times. The technology incorporates built-in digital cameras with LED lights and sensing electrodes on the balloon which allow for real-time visualization and assessment of catheter electrode contact. This is intended to provide physicians with higher confidence of effective energy delivery and the ability to customize the amount of energy delivered around the circumference of the balloon, while further reducing procedure times when compared to existing balloon technologies.

"The acquisition of Apama further advances our continued investment in the electrophysiology category, and, upon commercialization, would broaden our portfolio of differentiated arrhythmia solutions," said Joe Fitzgerald, president of rhythm management, Boston Scientific. "We are also excited about the ability to integrate the Apama RF balloon system with our Rhythmia HDx Mapping System to provide physicians with an unprecedented visualization of the heart during ablation procedures."

Initial results of AF-FICIENT, a first-in human study presented at the AF Symposium annual meeting in January 2017, demonstrated the Apama RF balloon met the safety and efficacy study endpoints, achieving successful PVI in patients with paroxysmal AF.

"Study results reinforce the Apama RF balloon is an advancement in single-shot technology for PVI and can provide physicians with greater control and efficiency when performing AF ablations," said Kenneth Stein, M.D., senior vice president and chief medical officer, rhythm management and global health policy, Boston Scientific. "We look forward to continuing the development and commercialization of this novel ablation solution to treat both paroxysmal and persistent AF."

The Apama RF balloon is currently being studied in clinical trials in Europe to serve as the basis for CE mark approval, which is expected in late 2018.

Apama is based in Campbell, California, with approximately 40 employees.

The acquisition is projected to close during the fourth quarter of 2017, subject to customary closing conditions.

On an adjusted basis, the transaction is expected to be immaterial to Boston Scientific adjusted earnings per share for 2017 and 2018. The transition is expected to be more dilutive on a GAAP basis, due to amortization expense, transaction, and integration related costs.

The Apama RF Balloon Catheter System is a concept device and not available for sale. 

For more information: www.bostonscientific.com

 

Related Content:
VIDEO: Current State of Atrial Fibrillation Ablation Technologies

What is New in Electrophysiology Technologies

Multi-Electrode RF Balloon Efficient for Acute Pulmonary Vein Isolation

VIDEO: Editor's Choice of Most Innovative New Technology at HRS 2017
 

Reference:
 1. Chugh SS, Havmoeller R, Narayanan K, et al. “Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study.” Circulation. 2014 Feb 25;129(8):837-47. doi: 10.1161/CIRCULATIONAHA.113.005119. Epub 2013 Dec 17.
 

Related Content

Biosense Webster Announces Initial Results From First-in-Human QDOT-FAST Study
News | Ablation Systems | May 16, 2019
Johnson & Johnson Medical Devices Companies announced that Biosense Webster, Inc.’s QDot Micro catheter...
CardioFocus Announces Results From HeartLight X3 Ablation System Pivotal Study
News | Ablation Systems | May 16, 2019
CardioFocus Inc. announced the presentation of results from its pivotal confirmatory study evaluating the HeartLight X3...
New Global Consensus Statement Addresses Catheter Ablation of Ventricular Arrhythmias
News | Ablation Systems | May 14, 2019
The Heart Rhythm Society (HRS) in partnership with three other professional societies issued an international consensus...
Netherlands Hospital to Install State-of-the-Art MRI Ablation Center
News | Ablation Systems | May 13, 2019
Imricor announced the signing of a commercial agreement with the Haga Hospital in The Hague, Netherlands to outfit a...
A CyberHeart cardiac ablation radiotherapy treatment plan showing where the radiation beam will ablate for a noninvasive pulmonary vein isolation procedure. Varian acquires, buys, purchases Cyberheart.

A CyberHeart cardiac ablation radiotherapy treatment plan showing where the radiation beams will ablate for a noninvasive pulmonary vein isolation procedure to treat an arrhythmia.

Feature | Ablation Systems | May 10, 2019 | Dave Fornell, Editor
May 10, 2019 — Radiation oncology vendor Varian announced it acquired the start-up company CyberHeart, which has deve
Ablation Reduces Risk of Dementia in Patients With AFib and Carotid Artery Disease
News | Ablation Systems | May 08, 2019
Even though many medical practitioners may opt not to perform procedures on higher-risk patients, new research finds it...
CardioFocus Announces European CE Mark Approval Of HeartLight X3 System
News | Ablation Systems | April 16, 2019
CardioFocus Inc. announced the European CE Mark approval of the HeartLight X3 Endoscopic Ablation System.
First Patient Treated With QDot Micro Ablation Catheter
News | Ablation Systems | February 04, 2019
Biosense Webster has enrolled and treated the first patient in its U.S. Investigational Device Exemption (IDE) study...
FDA Approves TactiCath Contact Force Ablation Catheter, Sensor Enabled
Technology | Ablation Systems | January 21, 2019
Abbott announced U.S. Food and Drug Administration (FDA) approval of the TactiCath Contact Force Ablation Catheter,...
First Patient Treated in STELLAR Atrial Fibrillation IDE Study
News | Ablation Systems | November 30, 2018
Johnson & Johnson Medical Devices Companies announced that Biosense Webster Inc. has enrolled and treated the first...
Overlay Init