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The Angiojet is a very small device that was originally approved in 1997 for use in keeping blood clots from clogging the dialysis grafts necessary to treat patients with kidney failure. In 1999, the device was approved for dissolving potentially deadly blood clots in a patient’s coronary arteries before the patient undergoes a balloon angioplasty (often with stenting), which may help prevent heart attack. It may also be used to reopen coronary bypass grafts that have closed as well as stents that have become clogged. Finally, the Angiojet is approved to remove blood clots in clogged arteries outside the heart (peripheral disease artery).
The Angiojet consists of three parts:
- Catheter. This is a thin, hollow tube that allows the Angiojet to be inserted into an artery, usually the femoral artery in the patient’s groin, and guided to the site of the blood clot. Once the catheter is in place, the Angiojet is activated.
- Pump set. Once activated, the pump set delivers a high-pressure saline solution through the catheter and into the artery. This creates a strong vacuum in the artery, which breaks up the blood clot and pulls it back through the catheter and into the pump set. The entire process takes about one minute. Because the pump set is disposable, a different pump set is used for each patient.
- Drive unit. This powers the Angiojet and helps to assure the patient’s safety.
Because it destroys blood clots (also known as thrombi), the Angiojet System is classified as a type of thrombolytic therapy. It offers a number of advantages over other forms of thrombolytic therapy:
- It works faster than clot-busting drugs, which are administered through an intravenous (IV) line into a patient’s arm for up to several hours for maximum effect. In contrast, the Angiojet system takes only minutes to complete. Furthermore, some patients are unable to take clot-busting drugs because of possible drug interactions or complicating health conditions. These patients are considered ideal candidates for the Angiojet System.
However, the Angiojet requires a hospital with a cardiac catheterization laboratory capable of performing the procedure. The time required to transfer and perform the procedure may be a factor in whether a patient is candidate for the device.
- It is less invasive than surgery. Patients require only a numbing medication (local anesthesia) and are awake the entire time that the Angiojet is being used. Also, recovery time is much faster than post-operative recovery time.
In December 2006, the original manuafacturer of the Angiojet was granted approval by the U.S. Food and Drug Administration (FDA) for a new Angiojet System. The new system, known as the Angiojet Ultra Thrombectomy System, is re-engineered version of the original device. Some of the benefits of the Ultra System include:
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Simpler set up process. As compared to the originla Angiojet, the Ultra System has fewer steps to set up the device for the procedure. Advanced microprocessors perform most of the steps and the remaining set up is minimal.
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Increased range of catheters. The Ultra System allows physicians to use a wider range of catheters, including those that are currently being used and catheters in development.
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New design. The Ultra System is lighter and sleeker than the original Angiojet drive unit. The more compact design makes it easier to maneuver around a medical facility.
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More advanced controls, The updated version provides an easier, more intuitive command system. It allows physicians greater flexibility in delivering drugs while removing blockages.
The Ultra System is expected to be fully released on the United States market by the summer of 2007.
Considering the Angiojet’s success with vascular and cardiovascular applications, researchers are looking for new uses for the Angiojet. Currently, studies are under way assessing the safety of using the Angiojet in the carotid arteries in the neck, which may help prevent stroke. Another recent study considered the use of the Angiojet in patients who are suffering from acute heart attack. This study did not support the use of the Angiojet in these patients, but studies are ongoing.
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