Surgical Product Guide » FDA Approval

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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Antibacterial Patch For Soft Tissue Repair

admin — Tue, 28 Sep 2010 10:23:38 +0000

TYRX, Inc. introduces AIGISRx® ST, its antibacterial product for the surgical repair of damaged or ruptured soft tissue. TYRX had previously received 510(k) clearance to market a product for hernia repair and other abdominal soft tissue deficiencies. The new clearance adds the use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue.

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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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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.

PolyTouch Medical Ltd. Receives FDA Clearance to Commercialize PatchAssist(TM)

admin — Wed, 23 Jun 2010 09:56:53 +0000

PolyTouch Medical Ltd. has announced that it has received broad FDA 510(k) clearance to commercialize PatchAssist(TM). PatchAssist is an innovative laparoscopic surgical instrument that enables accurate and rapid delivery and placement of soft tissue prosthetics for a variety of procedures, including laparoscopic ventral hernia repair (LVHR). PatchAssist enables surgeons to rapidly deliver and position soft tissue prosthetics over the defect potentially reducing operation time by 30% – 50%.

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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.

Endologix gets FDA approval for clinical trial

admin — Fri, 20 Nov 2009 11:12:04 +0000

Irvine-based Endologix has received Investigational Device Exemption conditional approval from the U.S. Food and Drug Administration to begin a clinical trial for a fully percutaneous approach to endovascular abdominal aortic aneurysm repair. The authorization allows the minimally invasive device maker to test the procedure using its IntuiTrak endovascular delivery system. AAA is a weakening of the walls of the aorta, which is the largest artery in the body.