Surgical Product Guide » FDA

ArthroCare Receives FDA Clearance for Parallax Contour Vertebral Augmentation Device

admin — Tue, 28 Sep 2010 10:30:02 +0000

ArthroCare Corp. announced that it has received clearance from the FDA to market its Parallax(R) Contour(R) Vertebral Augmentation Device (Contour) specifically for void creation in a vertebral body followed by injection of bone cement. Vertebral body void creation followed by bone cement augmentation is commonly used to treat painful vertebral compression fractures. The Contour device is indicated for use during kyphoplasty or vertebral augmentation procedures to create a void in the vertebral body.

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Integra LifeSciences Announces Launch of New Surgical Spine Instruments

admin — Thu, 23 Sep 2010 07:22:36 +0000

Integra LifeSciences Holdings Corporation has announced the introduction of a new line of extended length and “detachable” Ruggles(TM) kerrison rongeurs, which are key instruments used in a variety of neuro and spine surgeries. The Ruggles(TM) kerrison rongeurs with a detachable feature received 510(k) clearance from the United States Food and Drug Administration (FDA). The new feature allows for easier cleaning, and special coatings help preserve the instrument’s sharpness.

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Monteris Medical raises 3.4M Dollars for brain surgery device

admin — Wed, 08 Sep 2010 14:47:02 +0000

Monteris Medical Inc. has raised $3.4 million in equity for a device that enables minimally invasive laser surgery for brain tumors. Monteris’ AutoLITT System received clearance for use in neurosurgery from the FDA last year. The AutoLITT procedure uses an MRI to guide a laser that allows doctors to watch and adjust as they heat glioblastoma multiforme (GBM) tumors, reduce them to a pasty state and remove the tumor.

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Medyssey Spine Receives FDA 510(k) Clearance For Zenius(TM) Thoracolumbar Spinal System In Titanium Alloy (Ti6AL-4V ELI)

admin — Tue, 31 Aug 2010 08:41:37 +0000

South Korea-based Medyssey Co., Ltd. announced that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Zenius(TM) Thoracolumbar Spinal System. Though currently available in limited release, Medyssey will launch the new Zenius(TM) System in the United States in Q4. The Zenius(TM) System is a Ti alloy 5.5 mm Rod and Thoracolumbar Pedicle Screw Construct for the surgical treatment of spinal trauma, deformity, and degenerative spinal pathologies.

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FDA Concerned with Cancer Rates for New Spine Device

admin — Tue, 27 Jul 2010 08:39:07 +0000

FDA reviewers expressed concern with the increased number of cancer cases seen in degenerative disc disease patients implanted with an investigational Medtronic spine device compared with patients who underwent spinal fusion. The Amplify device stabilizes lower back vertebrae in patients with degenerative disc disease by using a compression resistant matrix and a metallic posterior spinal instrument. Amplify contains rhBMP-2, a morphogenetic protein that is added to the device to spur the formation of new bone.

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FDA Makes Class I Recall for Infusion Pumps

admin — Tue, 27 Jul 2010 08:33:47 +0000

The FDA initiated a class I recall its strictest of two infusion pumps released by a single company, due to a device error which may fail to recognize in-line air in infusions. Device manufacturer Hospira warned that failure to make corrective actions before device use may cause air to be delivered to the patient and cause serious injury or death. The company has not received any adverse event reports related to device failure.

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Baxter Infusion Pump Recall Requirements Issued By FDA

admin — Fri, 16 Jul 2010 09:57:16 +0000

The FDA has laid out requirements for the recall of Colleague Volumetric Infusion pumps by Baxter Healthcare Corp., instructing the company on how to refund or provide replacements for about 200,000 potentially dangerous infusion pumps. The FDA announced the infusion pump recall requirements, a little more than two months after it announced that Baxter would be forced to take its Colleague pump off of the market. Problems with Baxter Colleague infusion pumps have been linked to more than 500 deaths and 56,000 reports of adverse events.

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NuOrtho Gets Approval For Ceruleau

admin — Fri, 16 Jul 2010 09:05:00 +0000

NuOrtho Surgical, a surgical instrument developer based at the Advanced Technology and Manufacturing Center, has received FDA clearance to market its surgical probe. The approved probe, called Ceruleau, is NuOrtho’s first device to hit the market. NuOrtho received FDA clearance sooner than expected, Jeffrey Morrill, NuOrtho’s CEO, said. The company is now working to ramp up manufacturing and line up distributors. Within the next few months, as Ceruleau hits the market, the small company plans to hire about 20 people.
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FDA Clears Marketing of PatchAssist Laparoscopic Hernia Mesh Placement Device

admin — Thu, 08 Jul 2010 20:44:37 +0000

Israel’s PolyTouch Medical has received FDA clearance to market its PatchAssist laparoscopic hernia mesh placement device. The tool was developed to allow surgeons a more predictable and standardized approach to apply hernia patches. PatchAssist easily unfolds the mesh inside the abdominal cavity, accurately places the mesh over the hernia defect and enables surgeon to verify the mesh position before attachment is made. Patch Assist does not change laparoscopic techniques used today by surgeons, rather it eliminates manual, complicated, and time consuming tasks.

SafeStitch Medical, Inc. Receives FDA Clearance to Market the AMID StaplerTM for Hernia Repairs

admin — Fri, 11 Dec 2009 13:04:52 +0000

SafeStitch Medical, Inc. has announced that it has received 510(k) clearance from the FDA to market its AMID StaplerTM in the U.S. with the intended use in general surgery procedures for fixation of mesh, in the repair of hernia defects and in other surgical specialties for the approximation of tissues, including skin. The AMID Stapler™ is the first surgical stapler designed specifically for use in inguinal hernia repairs.