09.17.15
Medtronic plc has launched in the United States its Arc support catheter.
The device was developed to improve delivery of the company’s Solitaire stent retriever. Arc, according to the company, provides the fastest route to restoration of blood flow in patients with complex anatomy suffering acute ischemic stroke.
The Arc catheter series received U.S. Food and Drug Administration 510(K) clearance in July.
"The Arc support catheter establishes a new level of navigation performance for our most challenging patients," said Satoshi Tateshima, professor of neuro-interventional radiology at the University of California, Los Angeles. "When combined with Medtronic`s Solitaire stent retriever, this new system allows physicians to treat more challenging acute ischemic stroke patients and helps broaden our ability to service a larger segment of the population who suffer from this disease."
Recently, the American Heart Association/American Stroke Association (AHA/ASA) published new stroke treatment guidelines that recommend the use of stent retriever technology in conjunction with the current standard of care, tissue plasminogen activator (tPA, also known as IV-tPA, given through an IV in the arm)for eligible patients. The AHA/ASA guidelines are based on a panel of experts’ analysis of the results from five global clinical trials published in The New England Journal of Medicine (NEJM) that found the addition of stent retriever technology, a surgical procedure that manually removes blood clots from the brain, to current medical therapy such as IV-tPA, has a therapeutic benefit over medical therapy alone.
The primary stent retriever studied in the five global trials was the Solitaire device. Three of the five trials studied the Solitaire stent retriever exclusively. The Solitaire device was the only stent retriever that was used in every one of the five NEJM-published randomized trials.
"The Arc support catheter will complement our Solitaire stent retriever and demonstrates our organization`s focus on the treatment of stroke." said Brett Wall, president of the Neurovascular business, which is part of the Restorative Therapies Group at Medtronic. "The device also represents our organization`s ability to continue to deliver innovative technology."
The Arc support catheter includes a patent-pending manufacturing technology called a "progressive coil design" which gives the device its unique performance features.
Of the 695,000 acute ischemic stroke victims in the United States, about 240,000 are eligible for treatment with a stent retriever. However, while these devices are available at more than 500 U.S. hospitals in the only about 13,000 procedures are performed annually.
Medtronic is headquartered in Dublin, Ireland.
The device was developed to improve delivery of the company’s Solitaire stent retriever. Arc, according to the company, provides the fastest route to restoration of blood flow in patients with complex anatomy suffering acute ischemic stroke.
The Arc catheter series received U.S. Food and Drug Administration 510(K) clearance in July.
"The Arc support catheter establishes a new level of navigation performance for our most challenging patients," said Satoshi Tateshima, professor of neuro-interventional radiology at the University of California, Los Angeles. "When combined with Medtronic`s Solitaire stent retriever, this new system allows physicians to treat more challenging acute ischemic stroke patients and helps broaden our ability to service a larger segment of the population who suffer from this disease."
Recently, the American Heart Association/American Stroke Association (AHA/ASA) published new stroke treatment guidelines that recommend the use of stent retriever technology in conjunction with the current standard of care, tissue plasminogen activator (tPA, also known as IV-tPA, given through an IV in the arm)for eligible patients. The AHA/ASA guidelines are based on a panel of experts’ analysis of the results from five global clinical trials published in The New England Journal of Medicine (NEJM) that found the addition of stent retriever technology, a surgical procedure that manually removes blood clots from the brain, to current medical therapy such as IV-tPA, has a therapeutic benefit over medical therapy alone.
The primary stent retriever studied in the five global trials was the Solitaire device. Three of the five trials studied the Solitaire stent retriever exclusively. The Solitaire device was the only stent retriever that was used in every one of the five NEJM-published randomized trials.
"The Arc support catheter will complement our Solitaire stent retriever and demonstrates our organization`s focus on the treatment of stroke." said Brett Wall, president of the Neurovascular business, which is part of the Restorative Therapies Group at Medtronic. "The device also represents our organization`s ability to continue to deliver innovative technology."
The Arc support catheter includes a patent-pending manufacturing technology called a "progressive coil design" which gives the device its unique performance features.
Of the 695,000 acute ischemic stroke victims in the United States, about 240,000 are eligible for treatment with a stent retriever. However, while these devices are available at more than 500 U.S. hospitals in the only about 13,000 procedures are performed annually.
Medtronic is headquartered in Dublin, Ireland.