Abbott ACT I Carotid Stent Clinical Trial

Abbott Vascular ACT I is a prospective, randomized, multi-center trial that is enrolling a maximum of 1,658  patients, at up to 50 sites in North America.

ACT I is designed to demonstrate the non-inferiority of CAS when compared to carotid endarterectomy (CEA) for the treatment of asymptomatic carotid artery disease (CAD) in people at normal risk for surgery.

ACT I is using Abbott Vascular Emboshield BareWire Rapid Exchange Embolic Protection System with the Xact Rapid Exchange Carotid Stent System.

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Abbott ACT I Carotid Stent Clinical Trial

Abbott Vascular ACT I is a prospective, randomized, multi-center trial that is enrolling a maximum of 1,658  patients, at up to 50 sites in North America.

ACT I is designed to demonstrate the non-inferiority of CAS when compared to carotid endarterectomy (CEA) for the treatment of asymptomatic carotid artery disease (CAD) in people at normal risk for surgery.

ACT I is using Abbott Vascular Emboshield BareWire Rapid Exchange Embolic Protection System with the Xact Rapid Exchange Carotid Stent System.

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Christopher Metzger : Emboshield NAV6

"The innovative design of the Emboshield NAV6 offers marked improvements to an already good embolic protection system. It provides excellent steerable wire options to independently reach challenging lesions, a short basket length, significantly improved visibility, an easier-to-use retrieval system, and optimal pore size and distribution. These improvements make the NAV6 system an outstanding embolic protection device."

Christopher Metzger, MD
Holston Valley Medical Center

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Christopher Metzger : Emboshield NAV6

"The innovative design of the Emboshield NAV6 offers marked improvements to an already good embolic protection system. It provides excellent steerable wire options to independently reach challenging lesions, a short basket length, significantly improved visibility, an easier-to-use retrieval system, and optimal pore size and distribution. These improvements make the NAV6 system an outstanding embolic protection device."

Christopher Metzger, MD
Holston Valley Medical Center

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Jon Matsumura: Abbott PROTECT

"As a member of the PROTECT multispecialty Executive Committee, I have been impressed with the continuing downward trend in stroke rates with protected carotid stenting for patients at high risk for carotid endarterectomy from the earliest clinical trials with first-generation devices 10 years ago.”

“These results are related to several factors, including process of care improvements that skilled physicians are developing, and to the continuing improvements in device technology.”

“Abbott's PROTECT study represents state-of-the-art skills and technology for carotid artery stenting.”

Jon Matsumura, MD
Professor of Surgery
University of Wisconsin School of Medicine and Public Health

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Jon Matsumura: Abbott PROTECT

"As a member of the PROTECT multispecialty Executive Committee, I have been impressed with the continuing downward trend in stroke rates with protected carotid stenting for patients at high risk for carotid endarterectomy from the earliest clinical trials with first-generation devices 10 years ago.”

“These results are related to several factors, including process of care improvements that skilled physicians are developing, and to the continuing improvements in device technology.”

“Abbott's PROTECT study represents state-of-the-art skills and technology for carotid artery stenting.”

Jon Matsumura, MD
Professor of Surgery
University of Wisconsin School of Medicine and Public Health

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Charles Simonton Joins Abbott Vascular

Dr. Charles Simonton, medical director of clinical innovation and research at Carolinas Heart Institute, will be joining Abbott Vascular as divisional vice president and chief medical officer of the cardiac therapies group as of December 2007.

Dr. Simonton will be involved in the development of new coronary angioplasty and stent technology as well as interventional therapies for structural heart disease therapies, including PFO closure devices and percutaneous valves.

Dr. Simonton, who received his medical degree at Harvard and did his internship and residency at the University of California, plans to continue being active in physician education through the development and support of national and regional symposia that are designed to enhance physicians' knowledge base and technical expertise in interventional cardiology.

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Charles Simonton Joins Abbott Vascular

Dr. Charles Simonton, medical director of clinical innovation and research at Carolinas Heart Institute, will be joining Abbott Vascular as divisional vice president and chief medical officer of the cardiac therapies group as of December 2007.

Dr. Simonton will be involved in the development of new coronary angioplasty and stent technology as well as interventional therapies for structural heart disease therapies, including PFO closure devices and percutaneous valves.

Dr. Simonton, who received his medical degree at Harvard and did his internship and residency at the University of California, plans to continue being active in physician education through the development and support of national and regional symposia that are designed to enhance physicians' knowledge base and technical expertise in interventional cardiology.

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Emboshield BareWire Embolic Protection System

Abbott Vascular Emboshield Embolic Protection System employes BareWire technology where wire crosses the lesion first, independent of the filter and delivery catheter.

All other actions, including filter placement and retrieval, balloon dilatations, and stent placement then occur over the wire. The Emboshield is used mainly with Abbott Vascular Xact Carotid Stent System.

Abbott Vascular Emboshield Embolic Protection System

Five different wire support levels each available in two lengths of 190 cm and 315 cm featuring 0.014” rapid exchange system, Zebra stripes on proximal 8cm of wire to identify BareWire outside of its packaging, 0.019" step for filter retrieval at the end of the procedure,  3 cm shapeable platinum tip to aid delivery and appropriate sizing of the lesion and complete filter capture during retrieval

Abbott Vascular Emboshield Embolic Protection System  is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris)
while performing angioplasty and stenting procedures in carotid arteries.

The diameter of the artery at the site of the Filtration Element placement should be between 2.8 and 6.2 mm.

The Eemboshield is contraindicated for use in:

• Patients in whom anticoagulant and/or antiplatelet therapy is contraindicated.
• Patients with severe vascular tortuosity or anatomy that would preclude the safe
• introduction of the Guiding Catheter/ Introducer Sheath, BareWire, Delivery
• Catheter, Filtration Element, and/or Retrieval Catheter.
• Patients with a known hypersensitivity to nickel-titanium.
• Patients with uncorrected bleeding disorders.
• Lesions in the ostium of the common carotid artery

Read more...

Emboshield BareWire Embolic Protection System

Abbott Vascular Emboshield Embolic Protection System employes BareWire technology where wire crosses the lesion first, independent of the filter and delivery catheter.

All other actions, including filter placement and retrieval, balloon dilatations, and stent placement then occur over the wire. The Emboshield is used mainly with Abbott Vascular Xact Carotid Stent System.

Abbott Vascular Emboshield Embolic Protection System

Five different wire support levels each available in two lengths of 190 cm and 315 cm featuring 0.014” rapid exchange system, Zebra stripes on proximal 8cm of wire to identify BareWire outside of its packaging, 0.019" step for filter retrieval at the end of the procedure,  3 cm shapeable platinum tip to aid delivery and appropriate sizing of the lesion and complete filter capture during retrieval

Abbott Vascular Emboshield Embolic Protection System  is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris)
while performing angioplasty and stenting procedures in carotid arteries.

The diameter of the artery at the site of the Filtration Element placement should be between 2.8 and 6.2 mm.

The Eemboshield is contraindicated for use in:

• Patients in whom anticoagulant and/or antiplatelet therapy is contraindicated.
• Patients with severe vascular tortuosity or anatomy that would preclude the safe
• introduction of the Guiding Catheter/ Introducer Sheath, BareWire, Delivery
• Catheter, Filtration Element, and/or Retrieval Catheter.
• Patients with a known hypersensitivity to nickel-titanium.
• Patients with uncorrected bleeding disorders.
• Lesions in the ostium of the common carotid artery

Read more...

Abbott's Xact Carotid Stents System Wins FDA Approval

Abbott Vascular became the second firm approved to sell a carotid stent in the U.S., putting it into a market that analysts say could reach $1 billion in annual sales.

The FDA approved Abbott's Xact Carotid Stent System and its Emboshield Embolic Protection System on September 6th 2005 to treat patients at risk of stroke who aren't favorable candidates for surgery.  

Guidant received FDA approval last year for a similar carotid stent. Abbott hopes to capture 25 percent of the U.S. market in the product's first full year on the market and sustain that share as the market expands, the company said.

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Abbott's Xact Carotid Stents System Wins FDA Approval

Abbott Vascular became the second firm approved to sell a carotid stent in the U.S., putting it into a market that analysts say could reach $1 billion in annual sales.

The FDA approved Abbott's Xact Carotid Stent System and its Emboshield Embolic Protection System on September 6th 2005 to treat patients at risk of stroke who aren't favorable candidates for surgery.  

Guidant received FDA approval last year for a similar carotid stent. Abbott hopes to capture 25 percent of the U.S. market in the product's first full year on the market and sustain that share as the market expands, the company said.

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Abbott Vascular

Abbott Vascular, a division of Abbott, is one of the world’s leading vascular care businesses. Abbott Vascular is uniquely focused on transforming the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals.

Headquartered in Northern California, Abbott Vascular offers a comprehensive portfolio of vessel closure, endovascular and coronary products.

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Abbott Vascular

Abbott Vascular, a division of Abbott, is one of the world’s leading vascular care businesses. Abbott Vascular is uniquely focused on transforming the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals.

Headquartered in Northern California, Abbott Vascular offers a comprehensive portfolio of vessel closure, endovascular and coronary products.

Read more...

Abbott XACT Carotid Stent System

Abbott Vascular Xact Carotid Stent System is comprised of a delivery system and a self-expanding stent. The delivery system is a rapid exchange (RX) system designed to deliver the self-expanding stent to the carotid vasculature.

The self-expanding stent is cut from Nitinol tube into a flexible tubular prosthesis. Upon deployment of the stent into the carotid vasculature via the delivery system, the stent should appose the vessel wall and apply an outward pressure to establish patency.

The Xact stent is available in both tapered and straight configurations, with diameters ranging from 6 mm through 10 mm. Stent lengths range from 20 mm through 40 mm.

The delivery system has an outer diameter (OD) of 5.7 Fr and is compatible with 8 Fr guiding catheter or a 6 Fr sheath - with a 0.088” inner diameter or greater. The delivery system has a working length of 136 cm.

Abbott Vascular Xact Carotid Stent System (Xact), used in conjunction with the Emboshield Embolic Protection System, is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease and meet the following criteria:

1. Patients with symptomatic carotid artery stenosis with ≥ 50%  occlusion on ultrasound or angiography.
2. Patients with asymptomatic CAS with  ≥ 80%  occlusion on ultrasound or angiography

Patients must have a reference vessel diameter ranging between 4.8 mm and 9.1 mm at the target lesion.

Abbott Vascular Xact Carotid Stent System (Xact) is contraindicated in, but not limited to, the following situations:

• Patients in whom anticoagulant and / or antiplatelet therapy is contraindicated.
• Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of the Guiding Catheter / Introducer Sheath, BareWire, Emboshield Delivery Catheter, Filtration Element, and / or Retrieval Catheter.
• Patients with a known hypersensitivity to nickel-titanium.
• Patients with uncorrected bleeding disorders.
• Lesions in the ostium of the common carotid artery.

Read more...

Abbott XACT Carotid Stent System

Abbott Vascular Xact Carotid Stent System is comprised of a delivery system and a self-expanding stent. The delivery system is a rapid exchange (RX) system designed to deliver the self-expanding stent to the carotid vasculature.

The self-expanding stent is cut from Nitinol tube into a flexible tubular prosthesis. Upon deployment of the stent into the carotid vasculature via the delivery system, the stent should appose the vessel wall and apply an outward pressure to establish patency.

The Xact stent is available in both tapered and straight configurations, with diameters ranging from 6 mm through 10 mm. Stent lengths range from 20 mm through 40 mm.

The delivery system has an outer diameter (OD) of 5.7 Fr and is compatible with 8 Fr guiding catheter or a 6 Fr sheath - with a 0.088” inner diameter or greater. The delivery system has a working length of 136 cm.

Abbott Vascular Xact Carotid Stent System (Xact), used in conjunction with the Emboshield Embolic Protection System, is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease and meet the following criteria:

1. Patients with symptomatic carotid artery stenosis with ≥ 50%  occlusion on ultrasound or angiography.
2. Patients with asymptomatic CAS with  ≥ 80%  occlusion on ultrasound or angiography

Patients must have a reference vessel diameter ranging between 4.8 mm and 9.1 mm at the target lesion.

Abbott Vascular Xact Carotid Stent System (Xact) is contraindicated in, but not limited to, the following situations:

• Patients in whom anticoagulant and / or antiplatelet therapy is contraindicated.
• Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of the Guiding Catheter / Introducer Sheath, BareWire, Emboshield Delivery Catheter, Filtration Element, and / or Retrieval Catheter.
• Patients with a known hypersensitivity to nickel-titanium.
• Patients with uncorrected bleeding disorders.
• Lesions in the ostium of the common carotid artery.

Read more...

Abbott RX Accunet Embolic Protection System

Abbott Vascular RX ACCUNET Embolic Protection System is a .014” guide wire based filter system that utilizes rapid exchange technology so that the physician can easily control the filter during catheter manipulations. It is used mainly with the RX Acculink Carotid Stent System.

The RX ACCUNET is available in both 190 cm and 300 cm lengths with the proximal end of the 190 cm device coined to allow for attachment to a “DOC” wire extension.

Abbott Vascular RX ACCUNET Embolic Protection System

The system is 6F sheath/8F guide catheter compatible and has filters available in 4.5, 5.5, 6.5, and 7.5 mm basket diameters that are recommended for use in arteries ranging from 3.25 mm to 7.0 mm.

The RX ACCUNET’s flexible cage design assists in maintaining excellent wall apposition in pulsed flow environments and challenging anatomies.

The RX ACCUNET’s peel away delivery sheath allows for simple deployment with rapid exchange unsheathing for stability and ease of use.

The .014” wire can be torqued independently from the filter basket in order to help manage the navigation of tortuous anatomy. Recovery is performed with a choice of two dedicated RX recovery catheters.

The original RX ACCUNET Recovery Catheter has a shapeable distal tip designed to offer steering control during advancement. The RX ACCUNET 2 Recovery Catheter is lower profile and more flexible and was designed to access more tortuous anatomies without catching on stent struts.

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Abbott RX Accunet Embolic Protection System

Abbott Vascular RX ACCUNET Embolic Protection System is a .014” guide wire based filter system that utilizes rapid exchange technology so that the physician can easily control the filter during catheter manipulations. It is used mainly with the RX Acculink Carotid Stent System.

The RX ACCUNET is available in both 190 cm and 300 cm lengths with the proximal end of the 190 cm device coined to allow for attachment to a “DOC” wire extension.

Abbott Vascular RX ACCUNET Embolic Protection System

The system is 6F sheath/8F guide catheter compatible and has filters available in 4.5, 5.5, 6.5, and 7.5 mm basket diameters that are recommended for use in arteries ranging from 3.25 mm to 7.0 mm.

The RX ACCUNET’s flexible cage design assists in maintaining excellent wall apposition in pulsed flow environments and challenging anatomies.

The RX ACCUNET’s peel away delivery sheath allows for simple deployment with rapid exchange unsheathing for stability and ease of use.

The .014” wire can be torqued independently from the filter basket in order to help manage the navigation of tortuous anatomy. Recovery is performed with a choice of two dedicated RX recovery catheters.

The original RX ACCUNET Recovery Catheter has a shapeable distal tip designed to offer steering control during advancement. The RX ACCUNET 2 Recovery Catheter is lower profile and more flexible and was designed to access more tortuous anatomies without catching on stent struts.

Read more...

Abbott RX Acculink Carotid Stent System

Abbott Vascular RX Acculink Carotid Stent System (RX Acculink System) includes a self-expanding nickel-titanium stent pre-mounted on a rapid exchange stent delivery catheter. Radiopaque markers on the shaft mark the stent location.

The delivery system is comprised of a retractable sheath covering the stent during delivery, a radiopaque tip, an internal guide wire lumen, a handle assembly with a safety lock, and a pullback handle. Retracting the pullback handle removes the sheath and deploys the stent.

Upon deployment, the stent forms an open lattice, providing the scaffolding necessary to hold the artery open and ensure blood flow through the artery.

The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the following criteria:

• Patients with neurological symptoms and ≥50% stenosis of the common or internal carotid artery by ultrasound or angiogram
• Patients without neurological symptoms and ≥80% stenosis of the common or internal carotid artery by ultrasound or angiogram
  

Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.

The RX Acculink Carotid Stent System is contraindicated for use in:

• Patients in whom anti-coagulant and / or anti-platelet therapy is contraindicated.
• Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system, or stent system.
• Patients with known hypersensitivity to nickel-titanium.
• Patients with uncorrected bleeding disorders.
• Lesions in the ostium of the common carotid artery.

Read more...

Abbott RX Acculink Carotid Stent System

Abbott Vascular RX Acculink Carotid Stent System (RX Acculink System) includes a self-expanding nickel-titanium stent pre-mounted on a rapid exchange stent delivery catheter. Radiopaque markers on the shaft mark the stent location.

The delivery system is comprised of a retractable sheath covering the stent during delivery, a radiopaque tip, an internal guide wire lumen, a handle assembly with a safety lock, and a pullback handle. Retracting the pullback handle removes the sheath and deploys the stent.

Upon deployment, the stent forms an open lattice, providing the scaffolding necessary to hold the artery open and ensure blood flow through the artery.

The RX Acculink Carotid Stent System, used in conjunction with Abbott Vascular RX Accunet embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization and meet the following criteria:

• Patients with neurological symptoms and ≥50% stenosis of the common or internal carotid artery by ultrasound or angiogram
• Patients without neurological symptoms and ≥80% stenosis of the common or internal carotid artery by ultrasound or angiogram
  

Patients must have a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.

The RX Acculink Carotid Stent System is contraindicated for use in:

• Patients in whom anti-coagulant and / or anti-platelet therapy is contraindicated.
• Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system, or stent system.
• Patients with known hypersensitivity to nickel-titanium.
• Patients with uncorrected bleeding disorders.
• Lesions in the ostium of the common carotid artery.

Read more...