Abbott Announces Positive Clinical Results from Studies of FIRM-Guided Rotor Ablation for Atrial Fibrillation

ABBOTT PARK, Ill., June. 22, 2016 — Abbott announced today positive results from three clinical studies investigating the benefits associated with focal impulse rotor modulation (FIRM)-guided rotor ablation for atrial fibrillation. The investigator-sponsored studies, which evaluated the use of Abbott’s RhythmView® technology, were presented at CARDIOSTIM-EHRA EUROPACE 2016.

FIRM-guided therapy enables physicians to identify and locate rotors – unique patient-specific sources that sustain serious heart rhythm disorders, including atrial fibrillation. With the ability to visualize individual rotors, physicians can tailor treatment approaches for each patient.

“The latest data presented at Cardiostim adds to a growing body of clinical evidence in support of the FIRM-guided approach in combination with conventional ablation, with the goals of optimizing treatment planning for atrial fibrillation and improving long-term results for our patients,” said Prof. Stefan Spitzer of the Praxisklinik Herz und Gefäße in Dresden, Germany, who authored one of the data presentations at the conference. “I look forward to additional analyses that further investigate this important therapy option.”

The studies presented at Cardiostim investigated the benefits associated with FIRM-guided rotor ablation when combined with the traditional procedure for atrial fibrillation. Key findings include:

• Prof. Spitzer presented results from 58 patients finding 80.8 percent of patients free from atrial fibrillation at 12 months post-treatment with FIRM-guided ablation for redo cases of persistent atrial fibrillation, with 83 percent of patients having long-standing persistent atrial fibrillation.
• Dr. Tamas Szili-Torok (Rotterdam, Netherlands) presented the first results from the European-Focal Impulse and Rotor Modulation Registry (E-FIRM) of 138 patients showing 78 percent and 72 percent of patients in sinus rhythm following treatment with the FIRM-guided ablation at 6 and 12 months, respectively.
• Dr. Haroon Rashid (Falls Church, Va.) shared data examining the relationship between stable rotors and obstructive sleep apnea in 47 patients showing 78.6% of patients in sinus rhythm after FIRM-guided ablation, despite the presence of obstructive sleep apnea.

During a FIRM-guided rotor ablation procedure for atrial fibrillation, physicians use Abbott’s proprietary technology to identify and visualize rotors, important sustaining mechanisms of cardiac arrhythmias. Because arrhythmias develop as a result of both electrical and anatomic abnormalities, every patient needs to be individually diagnosed and treated. The system offers a patient-specific solution that enables physicians, for the very first time, to identify and ablate the unique sources that sustain serious heart rhythm disorders.

“The data presented at Cardiostim last week affirm the positive results achieved with the FIRM- guided approach,” said Michael Pederson, general manager of Abbott's electrophysiology business. “These results are consistent with the findings of the CONFIRM and OASIS studies, which show a clear incremental benefit associated with the use of rotor mapping when performed in conjunction with the traditional ablation procedure.”

About Atrial Fibrillation
Atrial fibrillation is the most common heart rhythm disorder, affecting more than 30 million people worldwide, with five million new cases reported annually. Globally, high blood pressure and obesity are the top risk factors for atrial fibrillation, which has a significant impact on healthcare costs.

Treatment options include medications, which do not address the underlying problem, and minimally invasive, catheter-based ablation procedures, which are designed to disrupt the transmission of abnormal impulses in the heart but have limited effectiveness with the current technology. Today, less than 3 percent of the approximately 12 million patients diagnosed with atrial fibrillation in the U.S., Europe, and Japan are treated with catheter ablation, with the majority of ablations performed on less sick patients. This results in a large, unmet clinical need, especially for sicker atrial fibrillation patients.

About Abbott
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritional and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 74,000 people.

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Abbott Media:
Nicole Osmer, 650-454-0454