DiamondTemp Ablation System Represents Disruptive RF Innovation
DUBLIN - January 24, 2019 - Medtronic plc (NYSE: MDT) today announced that it has entered into a definitive agreement to acquire EPIX Therapeutics, Inc. (EPIX), a privately-held medical device company that designs and manufactures a novel, catheter-based, temperature-controlled cardiac ablation system for the treatment of patients with cardiac arrhythmias (irregular heartbeats), including atrial fibrillation (AF). When completed, the EPIX acquisition will expand the Medtronic cardiac ablation portfolio to offer physicians a comprehensive suite of tools to treat patients with cardiac arrhythmias.
EPIX's flagship technology, the DiamondTemp(TM) ablation system, is a unique closed-loop, temperature-controlled system that provides physicians with improved feedback and control during an ablation procedure. The DiamondTemp system uses radiofrequency (RF) energy (heat) to create scar tissue in the heart and complements the Medtronic cryoballoon technology that uses cryo energy (cold) to isolate the pulmonary veins (PVI).
The DiamondTemp system received CE Mark in Europe in 2017 and is limited to investigational use in the U.S. The DIAMOND-AF trial, which completed enrollment in Oct. 2018, will support approval of the DiamondTemp system in the U.S. for patients with symptomatic paroxysmal AF (AF that starts and stops intermittently). Additionally, the DIAMOND-AF II trial, which is currently enrolling patients, is evaluating the DiamondTemp system in patients with persistent AF (AF that continues for long periods of time).
"The DiamondTemp ablation system stands out from other RF ablation technologies because of the real-time temperature control via rapid power modulation. This results in shorter procedure times and higher confidence in lesion quality," said Atul Verma, M.D., Southlake Regional Health Center in Newmarket, Canada, and global principal investigator for the DIAMOND-AF II study. "I've had the pleasure of working with EPIX to design the DIAMOND-AF II trial and I look forward to continuing that work with Medtronic."
"The DiamondTemp cardiac ablation system represents leapfrog technology in the RF cardiac ablation space, a segment of the market where we haven't previously participated," said Rebecca Seidel, vice president and general manager of the Atrial Fibrillation Solutions division, which is part of the Cardiac and Vascular Group at Medtronic. "When combined with our existing leading cryoballoon technology, we expect to provide physicians with a complete portfolio of best-in-class cryo and RF systems."
The EPIX acquisition is expected to close in Medtronic's fourth fiscal quarter, which runs January 26 to April 26, 2019, subject to the satisfaction of certain customary closing conditions. EPIX is currently pre-revenue, and although the acquisition is expected to be dilutive to Medtronic's near-term adjusted earnings per share, Medtronic intends to offset the dilution. The transaction is expected to meet Medtronic's long-term financial metrics for acquisitions. Additional terms of the transaction were not disclosed.
About the DiamondTemp Ablation System
The DiamondTemp ablation system is a temperature-controlled, irrigated RF ablation system for treating patients with AF. The DiamondTemp system is a closed-loop system with open irrigation and high-resolution electrograms, providing physicians with improved feedback and control during the ablation procedure which may improve AF treatment success.
About Cardiac Arrhythmias
Cardiac arrhythmia is a heart rhythm disorder, which can occur when there is a malfunction in the heart's electrical impulses that coordinate how it beats, causing the heart to beat too quickly, too slowly or in an irregular fashion. Some abnormal heart rhythms may not be serious or life threatening. Others, such as atrial fibrillation, may cause a patient to experience fainting, palpitations or a potentially life-threatening stroke. AF is one of the most common heart rhythm disorders, affecting more than 33 million people worldwide.1
About the Arctic Front Advance(TM)Cryoablation System
Cryoballoon ablation is used in a minimally invasive procedure to isolate the pulmonary veins, which are a source of erratic electrical signals that cause AF. The device uses cryo energy (cold) rather than radiofrequency (RF) (heat) to create scar tissue and interrupt irregular electrical pathways in the heart. More than 500,000 patients in more than 60 countries have been treated with the Medtronic Arctic Front Advance Cryoablation System. The system has CE Mark for the treatment of AF. In the U.S., the Arctic Front Advance Cryoablation System is approved for the treatment of drug refractory, recurrent, symptomatic paroxysmal AF.
About EPIX Therapeutics, Inc.
EPIX Therapeutics, Inc. is a medical device company that designs and manufactures a catheter-based system for the treatment of patients with cardiac arrhythmias, including AF. The company's mission is to dramatically improve the treatment of AF through the introduction of products based on its proprietary catheter and generator system. EPIX's technology is the only system in the world to leverage three unique capabilities: temperature sensing and feedback, low irrigation flow rates and high resolution electrogram attenuation. The DiamondTemp Ablation System is CE Marked and limited to investigational use in the U.S.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 86,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
DiamondTemp is a trademark of EPIX Therapeutics, Inc.
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1 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.
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