ANALIZE MEDICALE DE LABORATOR
Aici gasiti analizele medicale grupate pe categorii precum si detalii generale si specifice pentru categoriile respective.
Selectati o categorie din lista de mai jos:
Solutie antistress!
Construieste poduri :)
Prinde pisica neagra :)
FDA Approves Center Expansion Of Cardiovascular Systems, Inc. Clinical Trial Of The Orbital Atherectomy System
Cardiovascular Systems, Inc. (CSI) announced today that the U.S. Food and Drug Administration (FDA) has approved the expansion of the OASIS clinical trial from ten to 20 centers. The OASIS trial, sponsored by CSI, is being conducted to gather safety and
effectiveness data on the Orbital Atherectomy System (OAS). OAS is a
catheter-based system that uses a diamond coated crown to remove plaque
from peripheral arteries. The novel design of the OAS allows the crown to
create a final lumen about twice the size of the crown.
Michael J. Kallok, PhD, CSI's Chief Executive Officer said, "We are
pleased with the FDA's approval allowing us to expand the OASIS trial with
ten additional centers. With 20 active sites we will be able to continue
the pivotal trial at more centers and with more physicians. We expect this
will improve our ability to evaluate the Orbital Atherectomy System and
help validate its safety and effectiveness for treatment of PAD."
Over 12 million people in the US alone suffer from PAD which can cause
debilitating pain in the legs. If allowed to progress, PAD can lead to
Critical Limb Ischemia which may result in amputation of the leg if not
treated. It is estimated that less than two million people are actually
diagnosed with PAD and less than 700,000 are treated therapeutically each
year.
About CSI
Cardiovascular Systems, Inc. is an early stage medical device company
that has completed design, development, and testing of its Orbital
Atherectomy Device intended for removal of atherosclerotic blockages in
coronary and peripheral arteries. The Company's proprietary technology is
protected by over 20 issued US patents and corresponding foreign patents,
and several other pending patents. The Company has received 510(k)
clearance to market its Orbital Atherectomy System for treatment of
occluded AV Grafts used for hemodialysis access and has obtained CE mark
for peripheral vascular use.
Cautionary Statement for the Purpose of the "Safe Harbor" Provisions of
the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995, including our statement that the Company is
working on obtaining FDA approval of its IDE for use of the Orbital
Atherectomy System for treating blocked peripheral arteries. The
forward-looking statement is based upon current expectations and beliefs
and is subject to a number of factors and uncertainties that could cause
actual results to differ materially from those described in or anticipated
by the forward-looking statements. For example, our ability to obtain
approvals from the FDA depends upon the successful performance of our
product in testing and the submission to the FDA or other regulatory bodies
of appropriate evidence of such performance. We may encounter problems in
testing or regulatory review that delay or prevent us from obtaining such
approvals.
Cardiovascular Systems, Inc.
http://www.cardiovascularsystemsinc.com
FDA aprobã Centrul de extindere a cardiovasculare Systems, Inc studiu clinic Of The Orbital Atherectomy Sistem - FDA Approves Center Expansion Of Cardiovascular Systems, Inc. Clinical Trial Of The Orbital Atherectomy System - articole medicale engleza - startsanatate