Skip to main content

FDA Approves Trevo Device for Stroke


August 13, 2012 — The US Food and Drug Administration (FDA) has granted 510(k) market clearance for the Trevo Pro Retriever (Stryker Neurovascular), a clot retriever used in the setting of acute ischemic stroke.
Approval was based on the results of the TREVO 2 trial presented at the 2012 European Stroke Conference in May, where it compared favorably on rates of revascularization vs the currently available Merci Retriever, also a Stryker product.
Trevo Pro Retriever (Stryker Neurovascular)
"The launch of this device is another great stride in the evolution of stroke care," TREVO 2 investigator Gary Duckwiler, MD, from the University of California, Los Angeles, Medical Center, said in a statement released today by the company. "Concentric Medical, which is now owned by Stryker, has a long history of partnering with physicians to develop devices specifically designed to remove blood clots from a blocked artery in the brain. The Trevo Pro Retriever is easy to use and very effective at opening blood vessels, allowing physicians to have a significant impact on clinical outcomes."
TREVO 2
TREVO 2 was a randomized, core laboratory adjudicated clinical trial that compared the safety and efficacy of the Trevo retriever against that of the Merci Retriever. The new retriever uses the company's patented "Stentriever" technology, which the company describes as a novel method to retrieve clots from the neurovasculature.
The trial enrolled 178 patients from 27 institutions in the United States and Europe. The new retriever achieved significantly better post-device revascularization, with 86.4% of patients revascularized with the Trevo device vs 60% with the Merci Retriever, the company noted in a release in May.
Rates of functional independence, defined as a modified Rankin Scale score of 2 or less, were also higher with the Trevo device at 40% vs 21.8% with the Merci device. Other measures favored the Trevo device, including National Institutes of Health Stroke Scale scores and length of hospital stay.
Solitaire Device
The Trevo device is the second retriever approved this year, after 501(k) clearance was granted to the Solitaire Flow Restoration device (Covidien) in March.
Approval of that device was based on results of the Solitaire With the Intention for Thrombectomy (SWIFT) trial, which also compared the Solitaire device against the Merci Retriever.
Although SWIFT was a noninferiority trial, the results demonstrated superiority with the new retriever on several outcomes, said principal investigator Jeffrey L. Saver, MD, professor of medicine and director of the Stroke Center at the Geffen School of Medicine at the University of California, Los Angeles, when the trial was first presented at the International Stroke Conference in February 2012.
The results were reported by Medscape Medical News at that time.

Comments

Post a Comment

Popular posts from this blog

Contact Precautions May Have Unintended Consequences

Contact precautions, including gloves, gowns, and isolated rooms, have helped stem the transmission of hospital pathogens but have also had some negative consequences, according to findings from a new study. Healthcare worker (HCWs) visited patients on contact precautions less frequently than other patients and spent less time with those patients when they did visit, report Daniel J. Morgan, MD, from the University of Maryland School of Medicine and the Veterans Affairs (VA) Maryland Health Care System, Baltimore, and colleagues. Moreover, patients on contact precautions also received fewer outside visitors. "Less contact with HCWs suggests that other unintended consequences of contact precautions still exist," Dr. Morgan and coauthors write. "The resulting decrease in HCW contact may lead to increased adverse events and a lower quality of patient care due to less consistent patient monitoring and poorer adherence to standard adverse event prevention methods (such...
Post a Comment
Read more

CareFusion Issues Update on Infant Breathing Product Recall

July 5, 2012 — Medical device maker CareFusion has issued an update reminding healthcare providers of its voluntary recall of its Air Life ™ Infant Breathing Circuit, initiated back in May. The US Food and Drug Administration (FDA) has classified this action as a class 1 recall, meaning there is a reasonable probability of serious adverse health consequences or death associated with use of the defective units. The update was posted July 2 on the FDA  Website. On May 29, 2012, CareFusion sent an  Urgent Recall Notice  to customers and distributors stating that the company had identified potential risks associated with the Air Life  Infant Breathing Circuit. The action was initiated after the company received complaints of the Y adapter within the breathing circuit developing cracks during patient use. "If a crack develops in the Y adapter, this could potentially result in a leak in the closed ventilation system, leading to a loss in the intended tidal volum...
Post a Comment
Read more

FDA Approves Tapentadol ER for Diabetic Neuropathy

August 29, 2012 — The US Food and Drug Administration (FDA) has approved tapentadol extended-release (ER) ( Nucynta , Janssen Pharmaceuticals, Inc) for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) in adults for whom a continuous opioid analgesic is required over an extended time. It is the first opioid to receive this indication, the company notes in a statement today. DPN, the most common type of neuropathy, affects an estimated 16% of the more than 25 million Americans who have diabetes. The condition is often unreported and untreated, with an estimated 2 out of 5 cases not receiving care. Tapentadol ER is already approved for the treatment of moderate to severe chronic pain in adults requiring a continuous opioid analgesic for an extended period. It is a centrally acting synthetic analgesic, although the exact mechanism of action is unknown, the release states. "Although the clinical relevance is unclear," the company n...
4 comments
Read more