Abbott Receives U.S. Approval for New Device Designed to Treat Patients at Risk of Stroke

- Abbott Is Second to Market With Minimally Invasive Treatment for Carotid

Artery Disease -



15 Sep, 2005, 01:00 ET from Abbott

    ABBOTT PARK, Ill., Sept. 15 /PRNewswire-FirstCall/ -- Abbott (NYSE:   ABT)
 today announced it received U.S. Food and Drug Administration (FDA) approval
 for a new minimally invasive device to treat patients with carotid artery
 disease, a risk factor for stroke.  Abbott received FDA approval for the
 Xact(R) Carotid Stent and 510(k) clearance for the Emboshield(R) Embolic
 Protection System to treat patients at risk of stroke who are not favorable
 candidates for surgery.  With this, Abbott becomes the second company to enter
 the U.S. carotid stent market.
     "Surgery, or carotid endarterectomy, has proven a reliable method for
 treating carotid artery disease, but it is not the ideal treatment for
 everyone," said Gary S. Roubin, Ph.D., M.D., chairman of the department of
 interventional cardiology at Lenox Hill Hospital in New York.  "Some patients
 may stand to benefit more from a minimally invasive procedure with a carotid
 artery stent and embolic protection that avoids the risk associated with
 general anesthesia, eliminates the risk of cranial nerve injury and neck
 scarring.  The Xact Carotid Stent and Emboshield Embolic Protection System
 provide a truly advanced minimally invasive treatment alternative for these
 patients."
     "The launch of our carotid stent system in the United States is further
 evidence of the innovative line of vascular products Abbott has built that is
 gaining momentum in the interventional community," said Robert B. Hance,
 president of Abbott Vascular.  "We are delighted to see the benefits of
 clinical and scientific advancement at Abbott result in an important new
 treatment for patients at risk of stroke."
     The new system features a stent specifically designed to treat diseased
 carotid arteries -- arteries in the neck that have become clogged or partially
 blocked due to the build-up of fatty plaque and debris (atherosclerosis).  The
 Xact stent is self-expanding and has a closed-cell design that creates a
 tightly knit yet highly flexible mesh intended to help restore the inner
 diameter of a carotid artery, promote a smooth inner vessel surface, and
 potentially reduce the release of fatty debris (emboli) from a diseased vessel
 when it is treated, which can lead to stroke.
     The Xact stent is designed for use in combination with the fully
 retractable Emboshield filter.  Emboshield is designed to capture emboli that
 can break off during a carotid stenting procedure, and it is the only filter
 to feature Barewire(TM), a proprietary technology developed to allow for
 better control of stent placement once the filter is in place and fully
 apposed against the vessel wall.
     Abbott established an exclusive agreement to market and distribute
 Emboshield in February 2001 with Mednova Limited in Galway, Ireland, which
 developed the stent and filter.
     Abbott received approval and clearance for the Xact Carotid Stent and
 Emboshield Embolic Protection System based on its submission of SECuRITY
 Registry Study data in a Premarket Approval application filed in 2004.  Both
 Emboshield and Xact already have CE Mark approval and were launched in the
 European Union at the end of 2003.
     For important safety information regarding Abbott's Xact Carotid Stent and
 Emboshield Embolic Protection System, please visit
 http://www.abbottvascular.com/carotidfb .
 
     About The SECuRITY Registry Study
     The SECuRITY Registry Study was a prospective, multi-center, non-
 randomized trial involving 305 patients from 30 sites in the United States and
 Australia, designed to demonstrate the safety and effectiveness of the Xact
 Carotid Stent and Emboshield Embolic Protection System in treating carotid
 artery disease.  One-year findings showed that the Xact Carotid Stent, when
 used in conjunction with the Emboshield Embolic Protection System, provides a
 safe, effective and durable method that is comparable to carotid surgery for
 the treatment of carotid disease in patients deemed too high-risk for carotid
 endarterectomy (surgery).
 
     First Investigational Study In Asymptomatic Patients Underway
     In addition to receiving approval for its new carotid disease treatment
 system, Abbott is first to investigate the benefits of carotid artery stenting
 versus carotid artery surgery in the broader asymptomatic patient population -
 patients without symptoms of stroke who have carotid artery disease and who
 would otherwise be referred for surgery to treat their condition.
     Low-level carotid artery disease without stroke symptoms is common in the
 general population, but people with a high level (>70 percent stenosis) of
 carotid artery disease are at an elevated risk of having a stroke.(1)  The
 American Heart Association has estimated that approximately 75 percent of
 stroke patients do not have symptoms of the disease.(2)
     Abbott's ACT I (Asymptomatic Patients with Significant Extracranial
 Carotid Occlusive Disease Trial) is the first multi-center, randomized trial
 to compare the safety and effectiveness of carotid artery stenting with
 carotid artery surgery.  Abbott is conducting the ACT I trial with the Xact
 Carotid Stent and Emboshield Embolic Protection System.
 
     About Stroke and Carotid Artery Disease Treatment
     The American Heart Association estimates that 700,000 Americans will
 suffer a stroke this year and that 88 percent of strokes are ischemic,
 characterized by a loss of blood supply to the brain.(3)  Ischemic attacks are
 often caused by an embolism, a particle of atherosclerotic (fatty) plaque that
 breaks off from a diseased vessel and lodges in a smaller vessel, reducing or
 cutting off the blood supply to the area beyond the blockage.  Approximately
 30 percent of strokes are caused by embolic events originating from diseased
 carotid arteries.(4)
     The goal of carotid artery disease treatment is to restore adequate blood
 flow in the region of the artery that is blocked and to stabilize the fatty
 plaque in order to prevent plaque rupture that can create embolic debris
 leading to a stroke.  Patients with severe carotid blockages have
 traditionally been treated with carotid endarterectomy, a surgical procedure
 in which the artery is opened and the plaque is removed.
     Surgery can cause complications such as nerve damage and neck scarring.
 As a result, interventional physicians have started using less-invasive
 procedures, such as balloon angioplasty and stent placement, to treat carotid
 artery blockages in patients who are deemed at high risk for developing
 complications from surgery.  Patients who may be too high-risk for carotid
 surgery include patients with severe coronary artery disease, congestive heart
 failure, chronic obstructive pulmonary disease, previous carotid
 endarterectomy, radical neck surgery or radiation therapy.
 
     About Abbott Vascular
     Abbott Vascular, a division of Abbott, is transforming the treatment of
 vascular disease, combining the latest medical device innovations with world-
 class pharmaceuticals to advance medicine and improve patient care.  Abbott
 Vascular offers a comprehensive portfolio of vessel closure, endovascular and
 coronary products that are recognized internationally for their safety, ease
 of use and effectiveness in treating patients with vascular disease.  Abbott
 Vascular is headquartered in Redwood City, Calif.  For more information about
 Abbott Vascular, visit http://www.abbottvascular.com .
 
     About Abbott
     Abbott is a global, broad-based health care company devoted to the
 discovery, development, manufacture and marketing of pharmaceuticals and
 medical products, including nutritionals, devices and diagnostics.  The
 company employs more than 60,000 people and markets its products in more than
 130 countries.
     Abbott's news releases and other information are available on the
 company's Web site at http://www.abbott.com .
 
     Trademarks
     Xact and Emboshield are registered trademarks of Abbott, and Barewire is a
 trademark of Abbott.
 
     References
     (1) Al-Mubarak et al, Carotid Artery Stenting - Current Practice and
 Techniques, p. 9, Philadelphia, PA, Lippincott Williams & Wilkins, c.  2004.
 
     (2) Heart Disease and Stroke Statistics - 2004 Update, Dallas, TX:
 American Heart Association.  2003:1-52.
 
     (3) Heart Disease and Stroke Statistics - 2005 Update, American Heart
 Association
 
     (4) Al-Mubarak et al, Carotid Artery Stenting - Current Practice and
 Techniques, p.  48, Philadelphia, PA, Lippincott Williams & Wilkins, c.  2004.
 
 

SOURCE Abbott
    ABBOTT PARK, Ill., Sept. 15 /PRNewswire-FirstCall/ -- Abbott (NYSE:   ABT)
 today announced it received U.S. Food and Drug Administration (FDA) approval
 for a new minimally invasive device to treat patients with carotid artery
 disease, a risk factor for stroke.  Abbott received FDA approval for the
 Xact(R) Carotid Stent and 510(k) clearance for the Emboshield(R) Embolic
 Protection System to treat patients at risk of stroke who are not favorable
 candidates for surgery.  With this, Abbott becomes the second company to enter
 the U.S. carotid stent market.
     "Surgery, or carotid endarterectomy, has proven a reliable method for
 treating carotid artery disease, but it is not the ideal treatment for
 everyone," said Gary S. Roubin, Ph.D., M.D., chairman of the department of
 interventional cardiology at Lenox Hill Hospital in New York.  "Some patients
 may stand to benefit more from a minimally invasive procedure with a carotid
 artery stent and embolic protection that avoids the risk associated with
 general anesthesia, eliminates the risk of cranial nerve injury and neck
 scarring.  The Xact Carotid Stent and Emboshield Embolic Protection System
 provide a truly advanced minimally invasive treatment alternative for these
 patients."
     "The launch of our carotid stent system in the United States is further
 evidence of the innovative line of vascular products Abbott has built that is
 gaining momentum in the interventional community," said Robert B. Hance,
 president of Abbott Vascular.  "We are delighted to see the benefits of
 clinical and scientific advancement at Abbott result in an important new
 treatment for patients at risk of stroke."
     The new system features a stent specifically designed to treat diseased
 carotid arteries -- arteries in the neck that have become clogged or partially
 blocked due to the build-up of fatty plaque and debris (atherosclerosis).  The
 Xact stent is self-expanding and has a closed-cell design that creates a
 tightly knit yet highly flexible mesh intended to help restore the inner
 diameter of a carotid artery, promote a smooth inner vessel surface, and
 potentially reduce the release of fatty debris (emboli) from a diseased vessel
 when it is treated, which can lead to stroke.
     The Xact stent is designed for use in combination with the fully
 retractable Emboshield filter.  Emboshield is designed to capture emboli that
 can break off during a carotid stenting procedure, and it is the only filter
 to feature Barewire(TM), a proprietary technology developed to allow for
 better control of stent placement once the filter is in place and fully
 apposed against the vessel wall.
     Abbott established an exclusive agreement to market and distribute
 Emboshield in February 2001 with Mednova Limited in Galway, Ireland, which
 developed the stent and filter.
     Abbott received approval and clearance for the Xact Carotid Stent and
 Emboshield Embolic Protection System based on its submission of SECuRITY
 Registry Study data in a Premarket Approval application filed in 2004.  Both
 Emboshield and Xact already have CE Mark approval and were launched in the
 European Union at the end of 2003.
     For important safety information regarding Abbott's Xact Carotid Stent and
 Emboshield Embolic Protection System, please visit
 http://www.abbottvascular.com/carotidfb .
 
     About The SECuRITY Registry Study
     The SECuRITY Registry Study was a prospective, multi-center, non-
 randomized trial involving 305 patients from 30 sites in the United States and
 Australia, designed to demonstrate the safety and effectiveness of the Xact
 Carotid Stent and Emboshield Embolic Protection System in treating carotid
 artery disease.  One-year findings showed that the Xact Carotid Stent, when
 used in conjunction with the Emboshield Embolic Protection System, provides a
 safe, effective and durable method that is comparable to carotid surgery for
 the treatment of carotid disease in patients deemed too high-risk for carotid
 endarterectomy (surgery).
 
     First Investigational Study In Asymptomatic Patients Underway
     In addition to receiving approval for its new carotid disease treatment
 system, Abbott is first to investigate the benefits of carotid artery stenting
 versus carotid artery surgery in the broader asymptomatic patient population -
 patients without symptoms of stroke who have carotid artery disease and who
 would otherwise be referred for surgery to treat their condition.
     Low-level carotid artery disease without stroke symptoms is common in the
 general population, but people with a high level (>70 percent stenosis) of
 carotid artery disease are at an elevated risk of having a stroke.(1)  The
 American Heart Association has estimated that approximately 75 percent of
 stroke patients do not have symptoms of the disease.(2)
     Abbott's ACT I (Asymptomatic Patients with Significant Extracranial
 Carotid Occlusive Disease Trial) is the first multi-center, randomized trial
 to compare the safety and effectiveness of carotid artery stenting with
 carotid artery surgery.  Abbott is conducting the ACT I trial with the Xact
 Carotid Stent and Emboshield Embolic Protection System.
 
     About Stroke and Carotid Artery Disease Treatment
     The American Heart Association estimates that 700,000 Americans will
 suffer a stroke this year and that 88 percent of strokes are ischemic,
 characterized by a loss of blood supply to the brain.(3)  Ischemic attacks are
 often caused by an embolism, a particle of atherosclerotic (fatty) plaque that
 breaks off from a diseased vessel and lodges in a smaller vessel, reducing or
 cutting off the blood supply to the area beyond the blockage.  Approximately
 30 percent of strokes are caused by embolic events originating from diseased
 carotid arteries.(4)
     The goal of carotid artery disease treatment is to restore adequate blood
 flow in the region of the artery that is blocked and to stabilize the fatty
 plaque in order to prevent plaque rupture that can create embolic debris
 leading to a stroke.  Patients with severe carotid blockages have
 traditionally been treated with carotid endarterectomy, a surgical procedure
 in which the artery is opened and the plaque is removed.
     Surgery can cause complications such as nerve damage and neck scarring.
 As a result, interventional physicians have started using less-invasive
 procedures, such as balloon angioplasty and stent placement, to treat carotid
 artery blockages in patients who are deemed at high risk for developing
 complications from surgery.  Patients who may be too high-risk for carotid
 surgery include patients with severe coronary artery disease, congestive heart
 failure, chronic obstructive pulmonary disease, previous carotid
 endarterectomy, radical neck surgery or radiation therapy.
 
     About Abbott Vascular
     Abbott Vascular, a division of Abbott, is transforming the treatment of
 vascular disease, combining the latest medical device innovations with world-
 class pharmaceuticals to advance medicine and improve patient care.  Abbott
 Vascular offers a comprehensive portfolio of vessel closure, endovascular and
 coronary products that are recognized internationally for their safety, ease
 of use and effectiveness in treating patients with vascular disease.  Abbott
 Vascular is headquartered in Redwood City, Calif.  For more information about
 Abbott Vascular, visit http://www.abbottvascular.com .
 
     About Abbott
     Abbott is a global, broad-based health care company devoted to the
 discovery, development, manufacture and marketing of pharmaceuticals and
 medical products, including nutritionals, devices and diagnostics.  The
 company employs more than 60,000 people and markets its products in more than
 130 countries.
     Abbott's news releases and other information are available on the
 company's Web site at http://www.abbott.com .
 
     Trademarks
     Xact and Emboshield are registered trademarks of Abbott, and Barewire is a
 trademark of Abbott.
 
     References
     (1) Al-Mubarak et al, Carotid Artery Stenting - Current Practice and
 Techniques, p. 9, Philadelphia, PA, Lippincott Williams & Wilkins, c.  2004.
 
     (2) Heart Disease and Stroke Statistics - 2004 Update, Dallas, TX:
 American Heart Association.  2003:1-52.
 
     (3) Heart Disease and Stroke Statistics - 2005 Update, American Heart
 Association
 
     (4) Al-Mubarak et al, Carotid Artery Stenting - Current Practice and
 Techniques, p.  48, Philadelphia, PA, Lippincott Williams & Wilkins, c.  2004.
 
 SOURCE  Abbott