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AtriCure's Coolrail(TM) Linear Ablation Pen Receives FDA 510(k) Clearance
AtriCure, Inc.
(Nasdaq: ATRC), a medical device company and leader in cardiac surgical
ablation systems, announced that its Coolrail(TM) linear ablation pen
received 510(k) clearance from the FDA for the ablation of cardiac tissue.
Additionally, the first patient was successfully treated using the AtriCure
Coolrail(TM) Linear Ablation Pen. The Coolrail(TM) linear ablation pen and
ORLab(TM) system were used during a procedure performed by Dr. James R.
Edgerton, a prominent cardiac surgeon from the Cardiopulmonary Research
Science and Technology Institute of Dallas, Texas. The Coolrail(TM) linear
ablation pen is designed to facilitate the creation of an expanded cardiac
ablation lesion set during a minimally invasive off-pump procedure. The
ORLab(TM) system is a mapping, recording and stimulating system which
enables electrophysiologists and surgeons to confirm, in the operating
room, that the cardiac ablation lines being created are forming electrical
barriers, or lines of conduction block. The protocol used for mapping with
the ORLab(TM) system was developed by Dr. Warren M. Jackman, a prominent
electrophysiologist.
Dr. James R. Edgerton commented, "We are encouraged by the results of
the combined use of AtriCure's Coolrail(TM) pen and ORLab(TM) system to
more effectively perform an expanded cardiac ablation procedure. Based on
our previous research, we anticipate that our investigation of these new
products will demonstrate improved results in patients with persistent and
long- standing persistent atrial fibrillation." Dr. Warren Jackman
commented, "Based on our investigation and collaboration with Dr. Edgerton,
I believe that AtriCure's minimally invasive ablation platform has the
potential to become the standard of care for chronic atrial fibrillation
patients."
"We believe that the Coolrail(TM) pen combined with the ORLab(TM)
system will provide our Company with new market opportunities and broaden
the adoption of our minimally invasive products. The release of these new
products substantially strengthens our business and positions AtriCure to
pursue atrial fibrillation indications from the FDA for our minimally
invasive sole-therapy products," said David J. Drachman, President and
Chief Executive Officer. "During 2008 we plan on initiating enrollment in
our FDA regulated clinical trial, RESTORE SR-IIB. This prospective,
non-randomized, feasibility trial will enroll 25 patients at five leading
U.S. medical centers. The results of RESTORE SR-IIB will be used to design
and support U.S. pivotal trials of our minimally invasive sole-therapy
ablation system for the treatment of atrial fibrillation."
About AtriCure, Inc.
AtriCure, Inc. is a medical device company and a leader in developing,
manufacturing and selling innovative cardiac surgical ablation systems
designed to create precise lesions, or scars, in cardiac, or heart, tissue.
Medical journals have described the adoption by leading cardiothoracic
surgeons of the AtriCure Isolator(R) bipolar ablation system as a treatment
alternative during open-heart surgical procedures to create lesions in
cardiac tissue to block the abnormal electrical impulses that cause atrial
fibrillation, or AF, a rapid, irregular quivering of the upper chambers of
the heart. Additionally, medical journals and leading cardiothoracic
surgeons have described the AtriCure Isolator(R) system as a promising
treatment alternative for patients who may be candidates for sole-therapy
minimally invasive procedures. AF affects more than 5.5 million people
worldwide and predisposes them to a five-fold increased risk of stroke.
The FDA has cleared the AtriCure Isolator(R) bipolar ablation system,
including the new Isolator Synergy(TM) ablation clamps and multifunctional
and linear ablation pens, for the ablation, or destruction, of cardiac
tissue during surgical procedures. Additionally, the FDA has cleared
AtriCure's multifunctional pen for temporary pacing, sensing, stimulating
and recording during the evaluation of cardiac arrhythmias. To date, the
FDA has not cleared or approved AtriCure's products for the treatment of
AF. AtriCure's left atrial appendage clip system has not been approved for
commercial use. It is currently being used in clinical evaluations in
Europe.
Forward Looking Statements
This press release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995. Forward-
looking statements include statements that address activities, events or
developments that AtriCure expects, believes or anticipates will or may
occur in the future, such as earnings estimates, other predictions of
financial performance, launches by AtriCure of new products and market
acceptance of AtriCure's products. Forward-looking statements are based on
AtriCure's experience and perception of current conditions, trends,
expected future developments and other factors it believes are appropriate
under the circumstances and are subject to numerous risks and
uncertainties, many of which are beyond AtriCure's control. These risks and
uncertainties include the rate and degree of market acceptance of
AtriCure's products, AtriCure's ability to develop and market new and
enhanced products, the timing of and ability to obtain and maintain
regulatory clearances and approvals for its products, the timing of and
ability to obtain reimbursement of procedures utilizing AtriCure's
products, competition from existing and new products and procedures or
AtriCure's ability to effectively react to other risks and uncertainties
described from time to time in AtriCure's SEC filings, such as fluctuation
of quarterly financial results, reliance on third party manufacturers and
suppliers, litigation (including the purported class action lawsuit) or
other proceedings, government regulation and stock price volatility.
AtriCure does not guarantee any forward-looking statement, and actual
results may differ materially from those projected. AtriCure undertakes no
obligation to publicly update any forward-looking statement, whether as a
result of new information, future events or otherwise.
AtriCure, Inc.
http://www.atricure.com
AtriCure lui Coolrail (TM) liniara Ablation Pen, FDA a primit 510 (k) Clearance-ul - AtriCure's Coolrail(TM) Linear Ablation Pen Receives FDA 510(k) Clearance - articole medicale engleza - startsanatate