GOLD AF Registry to Capture Real-World Insights Using Medtronic Phased RF Ablation to Treat Patients with Atrial Fibrillation
April 07 2015 - 9:30AM
DUBLIN -
April 7, 2015 - Medtronic plc (NYSE: MDT) today announced the
first patient enrollment in the GOLD AF Registry, a
first-of-its-kind, prospective, observational clinical study of its
Phased Radiofrequency (RF) Ablation technology for treating
patients with symptomatic atrial fibrillation (AF). The multicenter
registry will provide real-world insights into the procedural use
and treatment outcomes of the Pulmonary Vein Ablation
Catheter® (PVAC) GOLD,
multi-electrode ablation catheter and other catheters that comprise
Medtronic's Phased RF technology.
The Medtronic Phased RF System is an innovative
generator and endocardial catheter system that delivers customized
RF energy to eliminate or block abnormal electrical impulses in the
left atrium that initiate or sustain AF. It has been used to treat
more than 30,000 patients and is approved in areas of Europe, Asia,
South Africa, Australia and Canada. The system is not approved in
the United States, but is under IDE study in the VICTORY AF
clinical trial.
"The GOLD AF Registry will give us the opportunity
to further evaluate and uncover best practices for treating
patients with Phased Radiofrequency technology," said Dr. L.V.A.
Boersma, cardiologist at St. Antonius Ziekenhuis Nieuwegein, The
Netherlands. "We'll be able to review data - in a very large
patient cohort - on the PVAC GOLD catheter, which maps, ablates and
validates pulmonary vein isolation quickly. Pulmonary vein
isolation is a clinically effective therapy for treating
symptomatic AF patients, and the goal of the PVAC GOLD catheter is
to allow physicians to effectively isolate the veins."
About the GOLD AF
Registry
The GOLD AF Registry will assess treatment by PVAC GOLD ablation of
patients with paroxysmal (occasional) or persistent AF, lone AF or
AF with underlying disease, and provide data on acute and mid-term
success rates, as well as other procedural details and patient
characteristics. It will enroll up to 1,000 patients at 50 sites in
11 countries: Belgium, France, Germany, Greece, Israel, Italy, The
Netherlands, Poland, Spain, Switzerland and the United Kingdom.
Patients will be observed for 12 months following a Phased RF
procedure. Principal Investigators are Dr. Boersma and Dr. Mèléze
Hocini, Centre Hospitalier Univeritaire de Bordeaux, France. The
first patient was enrolled at St. Johannes Hospital, Dortmund,
Germany, by Dr. med. Iskandar Djajadisastra.
"AF is a growing health concern that affects
millions of people worldwide. With the launch of the GOLD AF
Registry, we will have access to deeper clinical insights to help
us meet the needs of patients now and in the future," said Reggie
Groves, vice president and general manager of the AF Solutions
business, which is part of the Cardiac and Vascular Group at
Medtronic.
About the PVAC GOLD
Catheter
The PVAC GOLD catheter features improved thermal efficiency of gold
electrodes, compared to the platinum electrodes of the
first-generation system, to help physicians optimize RF ablation
therapy. By delivering RF energy through nine electrodes (either
all simultaneously or a subset of electrodes), the PVAC GOLD
catheter helps physicians safely and efficiently create consistent
lesions (intentional scar in the tissue) to effectively block the
erratic AF electrical currents coming from the pulmonary veins. The
gold electrodes provide four times the thermal conductivity of
their platinum predecessors, offering the potential for more
accurate temperature measurement and improved power
delivery1.
The catheter features an over-the-wire design and
an anatomic shape to help physicians safely position and stabilize
the catheter in different patient anatomies. A forward-tilted array
helps physicians find optimal placement that is designed to improve
uniformity of contact with the tissue. Following ablation,
the catheter is capable of verifying PV isolation through its
ability to pace and map.
In collaboration with leading clinicians,
researchers and scientists worldwide, Medtronic offers the broadest
range of innovative medical technology for the interventional and
surgical treatment of cardiovascular disease and cardiac
arrhythmias. The company strives to offer products and services
that deliver clinical and economic value to healthcare consumers
and providers around the world.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, is the global leader in medical technology - alleviating
pain, restoring health, and extending life for millions of people
around the world.
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.
-end-
1 Haines et al,
Evaluation of Gold/Platinum Electrode Multipolar Phased RF
Ablations in a Swine Model: Characteristics of Energy Delivery
Performance in a Swine Thigh Muscle Preparation, ESC Abstracts
2013
Contacts:
Tracy McNulty
Public Relations
+1-763-526-2494
Jeff Warren
Investor Relations
+1-763-505-2696
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Source: Medtronic plc via Globenewswire
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