Abbott stent products

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Deloose K. Absolute Pro Vascular utilizes a flexible stent material that is designed to conform to challenging lesions in the iliac arteries. The Absolute Pro Vascular Self-Expanding Stent System is indicated for improving luminal diameter in patients with de novo or restenotic atherosclerotic lesions in the native common iliac artery and native external iliac artery with reference vessel diameters between 4. This device is intended for single-use only; do not reuse. Do not resterilize.

Do not use if the package is open or damaged. The safety and effectiveness of multiple overlapping stents have not been established.

However, when multiple stents are required, stent materials should be of similar composition. Stenting across a major bifurcation may hinder or prevent future diagnostic or therapeutic procedures. Use of an undersized guide wire, with insufficient support, may cause kinking in the Stent Delivery System.

Inspect the product prior to use. Avoid unnecessary handling, which may kink or damage the Delivery System. Only physicians familiar with the complications, side effects and hazards commonly associated with iliac stent placement should use this device.

The stent is not designed for resheathing or recapturing. The stent is not designed for repositioning once the stent has apposed the vessel wall.

Once the stent is apposed to the vessel, it is not recommended to remove the stent with the delivery system. The Absolute Pro is intended to perform as a system. Do not remove the stent for use in conjunction with other dilatation catheters; do not use the Absolute Pro in conjunction with other stents. Refer to the instructions for use supplied with any interventional devices to be used in conjunction with the Absolute Pro for their intended uses, contraindications, and potential complications.

Do not attempt to pull a partially-expanded stent back through the introducer sheath or guiding catheter. The stent is not designed for recapturing. The stent is not designed for repositioning once the stent has apposed the vessel. Once the stent is apposed to the vessel, it is not recommended to remove the stent with the Delivery System.

Should unusual resistance be felt at any time during lesion access or removal of the Delivery System post stent implantation, the entire system should be removed together with the introducer sheath or guiding catheter as a single unit. Failure to follow these instructions could result in failure to deploy, difficulties with deployment, partial stent deployment or deployment in an unintended location.

For placement in the iliac artery, patients with this implant may be scanned safely anytime after implantation under the following conditions:. For the SAR conditions above, the greatest in-vivo temperature rise was calculated to be 5. The calculations do not take into consideration the cooling effects of blood flow, and therefore, actual in-vivo rises are expected to be lower.

The effects of MRI on overlapped stents greater than mm in length or stents with fractured struts are unknown. The image artifact both inside and outside the device lumen extends approximately 5 mm from the device using the spin echo sequence and 10 mm from the device using the gradient echo sequence. MR image quality may be compromised if the area of interest is in the exact same area, or relatively close to, the position of the Absolute Pro stent.

Therefore, it may be necessary to optimize the MR imaging parameters in the presence of Absolute Pro stents. The MedicAlert Foundation can be contacted by phone at:or on the internet at www. Prior to use, please reference the Instructions for Use at eifu. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates.

No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. Excellent precision, flexibility and proven clinical results in the iliacs.September 8, — Abbott Vascular has announced it will end commercial sales of its Absorb bioresorbable vascular scaffold as of Sept.

The company said low sales of the bioabsorbable stent led to the decision to stop offering the product. Sales of Absorb will end in all countries, according to Abbott. The company plans to continue the ongoing Absorb clinical trials to assess long-term outcomes after the scaffold has dissolved.

Abbott said trial centers can continue to use their existing Absorb inventory, but as of Sept. The vendor also stated it will focus efforts on a next generation metallic DES, the Xience Sierra, which is supposed to offer improved deliverability and expanded sizes.

The Absorb stent was originally hailed as a major advance forward in coronary stent technology when it received regulatory approval for commercial sales in Europe in and the United States in July However, as use of the stent expanded and new trial data revealed, it was found the scaffold has several limitations compared to metallic stents. These include delivery issues due to the thicker struts, stent recoil, the limited ability to over-expand without breaking struts, the need for very precise sizing, and poor outcomes if the Absorb is used in coronary vessels 2.

Perhaps the biggest barrier to wider adoption was the much higher price tag for Absorb over traditional metallic DES. While the Absorb also has some advantages over metallic stents, these were not enough to persuade interventional cardiologists to increase their usage.

These issues were brought up in discussions at numerous sessions that involved bioresorbable stents at the American College of Cardiology ACC meeting in March. Experienced users of the Absorb in trials said the stent can be used effectively, but that the new technology has a learning curve and it is not simply a replacement for metallic stents interventionalists have been using for two decades.

Stephen Ellis, M. Bioresorbable Stents Are the Way of the Future. Abbott makes the Xience stent used in the trial, which compared equally with long-term CABG surgical outcomes. This is a realistic cath lab simulator training set up shown by Mentice.

THE BEST STENT WE'VE EVER MADE

The patient has respiratory chest motion, eyes blink and it allows for radial or femoral catheterization. The simulator allows for PCI training. When not used for cath training, the patient simulator can be used by other hospital staff training or EMS training. Marco Costa, M. Low sales cited as reason for discontinuing commercial sales of the Absorb. News Cath Lab April 07, April 7, — Boston Scientific Corp.

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Photovoltaic Stents. Maxillofacial surgery instrument surgical instruments prices autoclave. Cortical Cortex screws 3. China 4.Potential adverse events that may occur during or after a procedure placing this device include, but are not limited to:. The hemodynamic data are used by physicians for heart failure management and with the goal of reducing heart failure hospitalizations. Potential Adverse Events: Potential adverse events associated with the implantation procedure include, but are not limited to the following: Infection, Arrhythmias, Bleeding, Hematoma, Thrombus, Myocardial infarction, Transient ischemic attack, Stroke, Death, and Device embolization.

Refer to the User's Manual for detailed indications, contraindications, warnings, precautions and potential adverse events. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

However, the patient's particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated. Adverse Events : Possible adverse events in alphabetical order associated with the device, include the following: Allergic reaction, Bleeding, Chronic nerve damage, Erosion, Excessive fibrotic tissue growth, Extrusion, Formation of hematomas or cysts, Infection, Keloid formation and Migration. Additional information : Clinicians must log onto Merlin.

On Merlin. Review of transmissions is dependent on the clinician and may not happen immediately following delivery of such transmissions. Data is resent if the transmission was not sent successfully.

However, there are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of ICM and patient information as intended by the clinician. An Abbott mobile transmitter is available for patients without their own compatible mobile device. This device may also be used to replace a previously implanted mitral or aortic prosthetic heart valve. Any sizer sterilization method other than steam is contraindicated. Complications associated with replacement mechanical heart valves include, but are not limited to, hemolysis, infections, thrombus, or thromboembolism, valve dehiscence, unacceptable hemodynamic performance, hemorrhagic complications secondary to anticoagulation therapy, heart block requiring pacemaker implant, prosthetic failure, adjacent cardiac structure interference, heart failure, stroke, myocardial infarction, or death.

Any of these complications may require reoperation or explantation of the device. The Supera Peripheral Stent System should only be used by physicians and medical personnel trained in vascular interventional techniques and trained on the use of this device. A patient with this device can be scanned safely only under specific conditions.

Failure to follow the conditions may result in severe injury.

abbott stent products

A patient with this stent can be scanned safely, immediately after placement, under the following conditions:. The legs of the patient should not be touching during the procedure. It is designed to replace blood glucose testing for diabetes treatment decisions. The System detects trends and tracks patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.

The System is intended for single patient use and requires a prescription. The exposure may damage the Sensor and may impact proper function of the device which could cause incorrect readings. They are grouped into categories for easy reference. Read this section to gather important prescription and safety information.

For specific indications, contraindications, instructions, warnings, precautions, and adverse effects about system components available in your country or region, see the approved clinician's manual for those components. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. The system is intended to be used with leads and associated extensions that are compatible with the system. The following procedures are contraindicated for patients with a deep brain stimulation system.Learn about our innovative portfolio of breakthrough cardiovascular products.

From essential vascular devices to next-generation technologies, our products are helping lay the foundation for better health outcomes every day. Minimally invasive treatments help speed recovery and let people get back to their daily activities faster with fewer complications, allowing healthier lives for millions of people worldwide.

Resolute Integrity Coronary Stent System

We have an industry-leading pipeline and comprehensive portfolio of products for cardiac and vascular care. Visit Our Website. Contact Us. Innovative, first-in-class therapies to serve the unmet needs of patients with structural heart defects.

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Explore Our Products. An extensive portfolio of drug-eluting stents, bare metal stents, coronary guide wires, balloon dilatation catheters, and guiding catheters and accessories that help provide innovative, minimally invasive and cost-effective treatment of coronary artery disease.

A full range of products designed for peripheral intervention including peripheral stents, peripheral guide wires, dilation catheters and guiding catheters. Suture-mediated and vascular closure products designed to facilitate secure closure of the vascular access site after diagnostic or interventional catheterizations.

Two distinct carotid stents and embolic protection systems to offer physicians a choice in systems to best meet their patients' needs. Our commitment is to help you deliver the highest quality care to every patient. For us that means creating innovative solutions that meet a range of needs—from training and patient support programs, to economic value services, to improving patient access.

We partner with our customers to provide services that support them across multiple facets of providing exceptional patient care. Education and Training.

abbott stent products

Multimedia Center. Customer Service. Please be aware that the website you have requested is intended for the residents of a particular country or region, as noted on that site. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions. The website you have requested also may not be optimized for your specific screen size. Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site.Here is the key information you need to help ensure patient access to cardiovascular care that requires advanced medical technology.

Providers should consult with their payers regarding appropriate documentation, medical necessity and coding information consistent with individual payer requirements and policies. For a description of Abbott products related to interventional cardiology and peripheral intervention, please see Products.

Effective January 1,hospitals are required to use Medicare C-Codes when billing for devices used in the outpatient setting. Requiring the use of C-Codes to identify devices used in conjunction with procedures paid for under OPPS will greatly improve the quality of claims data Medicare uses to establish APC payments in the future. The full list of C-codes can be found on the CMS website. Medicare has established outpatient coding edits dictating which specific C-Codes should be billed with which CPT procedure code.

The list of coding edits is not all-inclusive and Medicare will add edits to the list on a quarterly basis in conjunction with the quarterly Outpatient Coding Editor OCE release. For a description of Abbott interventional cardiology products, please click here: Products.

The C-Code is used primarily for internal charging to capture the cost of the embolic protection system. Abbott provides summaries of Medicare hospital and physician policy and reimbursement information. Please click the links below to download the Medicare Reimbursement Guides. Providers should consult with their payers regarding appropriate documentation, medical necessity, and coding information consistent with individual payer requirements and policies.

Below you will find general coding information related to carotid artery stenting. Note: Carotid artery stenting is covered as an inpatient procedure only. Coverage is limited to procedures performed using FDA-approved carotid artery stents and FDA-approved or -cleared embolic protection devices. The use of an FDA-approved or cleared embolic protection device is required. If deployment of the embolic protection device is not technically possible, and not performedthen the procedure is not covered by Medicare 1.

All rights reserved. Note: Currently, carotid artery stenting is covered and paid only as an inpatient procedure.

abbott stent products

Medicare hospital inpatient information is effective for the fiscal year FY October 1 through September Since that time, CMS has published multiple related coverage policies for carotid artery stenting.