Devices

CDRH Allows Marketing of Clot Removal Device

CDRH has allowed under its de novo review the marketing of Concentric Medical’s two Trevo clot retrieval devices as an initial therapy for strokes due to blood clots to reduce paralysis, speech difficulties and other stroke disabilities. These devices should be used within six hours of symptom onset and only following treatment with a clot-dissolving drug (tissue plasminogen activator or t-PA), which needs to be given within three hours of symptom onset, an FDA release says. The Trevo device was first cleared by the agency in 2012 to remove a blood clot and restore blood flow in stroke patients who could not receive t-PA or for those patients who did not respond to the therapy.

The device is inserted through a catheter up into the blood vessel to the site of the blood clot. When the end is fully expanded, it grips the clot, allowing the physician to retrieve the clot by pulling it back through the blood vessel along with the device for removal through the catheter or sheath, the agency says.

To allow marketing, CDRH evaluated data from a clinical trial comparing 96 randomly selected patients treated with the Trevo device along with t-PA and medical management of blood pressure and disability symptoms with 249 patients who had only t-PA and medical management. ”Twenty-nine percent of patients treated with the Trevo device were functionally independent (ranging from no symptoms to slight disability) three months after their stroke, compared to 19 percent of patients who were not treated with the Trevo device,” the Center says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome