New Clinical Study Will Evaluate MRI-Guided Laser Ablation for a Common Form of Epilepsy
June 17 2016 - 9:00AM
Drug-Resistant
Mesial Temporal Lobe Epilepsy Is the Focus of Medtronic's SLATE
Study
DUBLIN - June 17, 2016 -
Medtronic plc (NYSE: MDT) announced today the U.S. Food and Drug
Administration's (FDA) approval of the Investigational Device
Exemption (IDE) application for the pivotal SLATE (Stereotactic
Laser Ablation for Temporal Lobe Epilepsy) study. The clinical
investigation is designed to support the expanded indication of the
currently marketed Visualase(TM) MRI-Guided Laser Ablation
Technology for treatment of epilepsy in patients with
drug-resistant mesial temporal lobe epilepsy (MTLE), the most
common form of partial or localization related epilepsy.
"Surgery is an effective, though underused,
treatment for drug-resistant epilepsy. For some patients, laser
ablation offers a minimally-invasive treatment option," said
Michael Sperling, M.D., Baldwin Keyes professor of neurology at
Thomas Jefferson University and director of the Jefferson
Comprehensive Epilepsy Center at Thomas Jefferson University
Hospital in Philadelphia, Pa. "If demonstrated to be effective,
results from this clinical trial will help clinicians weigh the
risks and benefits of laser ablation when discussing treatment
options with their patients."
The study will include approximately 120 adult
patients with drug-resistant MTLE treated at selected epilepsy
centers across the United States. After the Visualase procedure,
patients will be followed for 12 months and evaluated for freedom
from seizures, quality of life, adverse events and
neuropsychological outcomes.
"This is a significant step in collecting evidence
regarding laser ablation as a treatment option for MTLE," said
Robert Gross, M.D., Ph.D, MBNA/Bowman professor of neurosurgery and
director, Functional, Stereotactic and Epilepsy Surgery Division at
Emory University in Atlanta, Ga. "We are eager to begin enrolling
patients."
Approximately three million people1
in the United States have epilepsy, and it is estimated that at
least one-third become drug resistant2, continuing
to have seizures regardless of the number or type of anti-epileptic
drugs used.
"Uncontrolled seizures lead to a wide
variety of medical consequences and can have significant lifestyle
and psychosocial impacts," said Scott Hutton, vice president and
general manager of the Neurosurgery business, which is part of the
Restorative Therapies Group at Medtronic. "We're hopeful that
people with drug-resistant MTLE can benefit from our innovative
Visualase technology."
About the Medtronic Visualase(TM)
System
The Visualase MRI-Guided Laser Ablation System is 510(k)
cleared by the FDA to necrotize or coagulate soft tissue in
neurosurgery and other surgical specialties. Through a minimally
invasive procedure, laser energy is delivered to the target area
using a laser applicator. As light is delivered through the laser
applicator, temperatures in the target area begin to rise,
coagulating the unwanted soft tissue under real-time MRI
guidance.
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 85,000 people worldwide, serving physicians,
hospitals and patients in approximately 160 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.
-end-
1
http://www.cdc.gov/epilepsy/basics/fast-facts.htm/ accessed June
2016
2 Kwan P,
Sander JW. The natural history of epilepsy: An epidemiological
view. J Neurol Neurosurg Psychiatry. V.75(10):2004; 75:
1376-1381.
Contacts:
Candy Bowen
Public Relations
+1-904-332-8163
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Medtronic plc via Globenewswire
HUG#2021365
Medtronic (NYSE:MDT)
Historical Stock Chart
From Mar 2024 to Apr 2024
Medtronic (NYSE:MDT)
Historical Stock Chart
From Apr 2023 to Apr 2024