SUNRISE, FL--(Marketwire - October 29, 2009) - Bolton Medical announced today the first use of
its new Relay Plus System in the U.S. Relay Clinical Trial. The case took
place at the University of Pennsylvania Medical Center in Philadelphia, PA.
Dr. Nimesh D. Desai noted that the surgery was successful and the Relay
Plus System allowed for easier access to the difficult-to-reach thoracic
aorta. He further commented that "the hydrophilic dual-sheath design in
the Relay Plus makes this device highly versatile in terms of tight access
vessels, and the additional sheath length provides better stability during
graft deployment."
"The Relay Plus System has a spiral support bar which allows the graft to
take the lesser curve without kinking and eliminates the notion of
'bird-beaking' gaps and 'no-man's land'. The system also has smaller
caliber devices (22 mm) which allows for repair of patients with smaller
diameter aortas," said Dr. Grace J. Wang.
Thoracic Stent-Grafts are an option to traditional open surgery for
patients requiring treatment for main thoracic pathologies. The
endovascular stent-graft procedure generally results in a reduced hospital
stay and a shorter recovery time for the patient.
The Relay Plus System offers new delivery system features to optimize
navigation and is designed for use with the Relay Thoracic Stent-Graft. It
was developed with feedback from participating physicians and offers the
following attributes:
-- Hydrophilic coating on the outer sheath and tip for easier
introduction and advancement through the aorta
-- Longer 60 cm braided outer sheath with enhanced radiopacity and
reinforced pushrod to facilitate pushability and visibility in challenging
aortic anatomies
-- New nitinol inner catheter to aid in the alignment of the dual sheath
system
-- Streamlined tip-sheath transition
Study Investigator Dr. Wilson Szeto stated, "I've had fantastic results
from the Relay trial. Here at UPENN, we've had no mortalities, no stroke
rate, and no vascular complications during the 2.5 years we've participated
in the trial. Bolton Medical has really fine-tuned the lessons learned
from other TAA products and incorporated them into a great product."
The two University of Pennsylvania surgeons who performed the procedure
were Dr. Nimesh D. Desai of the Division of Cardiovascular Surgery, and Dr.
Grace J. Wang of the Division of Vascular and Endovascular Surgery. The
Study Investigator at UPENN for the Relay Clinical Trial is Dr. Wilson
Szeto of the Division of Cardiovascular Surgery.
The Relay Plus System was CE marked in March of 2009 and is available in
Europe as well as countries worldwide that recognize the CE mark. It will
be marketed along with the original Relay Thoracic Stent-Graft System which
was launched in Europe in 2005 and is well underway in clinical trials in
the U.S.
Relay and Relay NBS Thoracic Stent-Grafts are indicated for the treatment
of main thoracic aortic pathologies such as aneurysms, penetrating ulcers,
pseudoaneurysms, and intramural hematomas in adult patients. It is
expected that by the end of 2009 more than 3500 Relay and Relay NBS
Stent-Grafts will have been implanted worldwide. For additional
information on the Relay clinical trial, please visit
www.relayclinicaltrial.com.
ABOUT BOLTON MEDICAL
Bolton Medical is a private company, with European operations based in
Barcelona, Spain, and U.S. operations in Sunrise, Florida. Bolton Medical
is a wholly-owned subsidiary of the Werfen Life Group, a diverse
manufacturer and supplier of products for the medical industry.
www.boltonmedical.com
