DUBLIN, Ireland--(BUSINESS WIRE)--Sep. 15, 2014--
plc announced today the start of enrollment in two clinical trials
designed to further underscore the safety and effectiveness of the
company’s advanced neurovascular solutions.
Medical Center in Jacksonville, Florida, treated the first patient
enrolled in the PREMIER Prospective study, an international
Investigational Device Exemption (IDE) clinical study to evaluate the Pipeline™
embolization device in smaller unruptured intracranial aneurysms.
Health Lexington in Kentucky, enrolled the first patient in the
STRATIS Registry for Endovascular Stroke Devices, which will evaluate
the use of all Covidien market-released stroke devices.
The PREMIER study will enroll up to 141 patients in 20 global sites and
is designed to assess the safety and effectiveness of the Pipeline
device in the treatment of unruptured, small and medium wide-necked
intracranial aneurysms (IAs).
“We are excited to be the first hospital to enroll a patient in this
important study. There is a need for an effective and sustained
treatment option for patients with wide neck small or medium
intracranial aneurysms,” said Ricardo Hanel, M.D., Ph.D., neurovascular
surgeon with Lyerly Neurosurgery at Baptist Medical Center. “Redirecting
blood flow away from the aneurysm with the Pipeline device has been
shown to reduce aneurysm recurrence and the need for retreatment in
large and giant internal carotid artery (ICA) aneurysms. This study will
provide valuable clinical evidence in a new population of aneurysms.”
The STRATIS Registry, a prospective, multi-center, non-randomized,
observational registry designed to evaluate the use of Covidien
endovascular stroke devices in patients diagnosed with an acute ischemic
stroke. Covidien’s current endovascular stroke device in the U.S. is the Solitaire™
2 revascularization device.
“The STRATIS Registry will assess mechanical thrombectomy (MT) as a
treatment option in patients who can’t get access to or are not eligible
for IV-tPA - a medication that dissolves blood clots,” said Curtis
Given, M.D., co-director of neurointerventional services at Baptist
Health Lexington. “It is very important to provide registry data to not
only demonstrate the safety of a MT procedure on these patients, but
also to track the outcomes, so we can compare the results to historical
IV-tPA data. In some states, insurance carriers are refusing to
reimburse MT procedures, so it’s vital that we collect the data to show
not only safety, but efficacy, in order to ensure that we can continue
to provide care to these patients that would otherwise not be offered
any treatment for their stroke.”
As many as 60 U.S. sites are expected to participate in the STRATIS
Registry, which will enroll up to 1,000 patients to collect clinical
outcomes for interventional stroke patients in a real world setting.
“Covidien continues to design outcomes-based clinical studies to confirm
the real world safety and effectiveness of its advanced neurovascular
technologies and explore new applications where there is a significant
unmet medical need for additional treatment options,” said Stacey Pugh,
vice president Medical Affairs, Neurovascular, Covidien. “The PREMIER
study underscores Covidien’s ongoing commitment to improve outcomes, and
expand the use of flow diversion technology as a primary treatment for
IA patients. We are confident that the STRATIS Registry will generate
real world evidence on patients treated with MT and will help improve
systems of care, resulting in better patient care and clinical outcomes.”
According to the World
Stroke Organization, nearly six million people worldwide die from
stroke each year.
Covidien is a global health care leader that understands the challenges
faced by providers and their patients and works to address them with
innovative medical technology solutions and patient care products.
Inspired by patients and caregivers, Covidien’s team of dedicated
professionals is privileged to help save and improve lives around the
world. With more than 38,000 employees, Covidien operates in 150-plus
countries and had 2013 revenue of $10.2 billion. To learn more about our
business visit www.covidien.com
or connect with us on Twitter.
David T. Young, 508-452-1644
Vice President, External Communications,
Lannum, CFA, 508-452-4343