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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Spectrum Surgical Instruments Corp. introduces the P.O.I. Biopsy Forcep. With its 2mm bite, the P.O.I. Biopsy Forcep allows the health care provider to take multiple, virtually painless cervical biopsies and allows for better visualization of exact location of the biopsy. The P.O.I. Biopsy is consistently more sensitive in detecting the presence of high-grade disease or cancer than traditional colposcopy directed biopsy. The German-made instrument is available in 9-inch (23cm) or 11-inch (28cm lengths).

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Integra Lifesciences Holdings Corporation has added a tissue sparing retraction system, iPASSAGE Retractor for Minimally Invasive Surgery of the lumbar spine. The iPASSAGE system allows the surgeon to make smaller cuts, thereby reducing the time of recovery, tissue damage and blood loss. Integra distributes the iPASSAGE Retractor system through Integra Spine, a part of the Orthopedics segment. The company’s spine and orthobiologics product portfolio includes spinal fusion devices; supplemental fixation systems for cervical procedures.

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Elmbrook Memorial, which began offering robotic surgeries earlier this year, celebrated its 100th robotic surgery. Elmbrook Memorial offers many types of robotic surgeries including prostate, urologic, gynecologic, gastric bypass, and colorectal. Using the da Vinci Surgical System, the surgeon operates while seated comfortably at a console viewing a 3D image of the surgical field. The surgeon’s fingers grasp the master controls below the display, with hands and wrists naturally positioned relative to his eyes.

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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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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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Micro Power Electronics, Inc. has announced the capability to manufacture rechargeable lithium-ion battery packs that can be sterilized via hydrogen peroxide gas without performance degradation. These battery packs provide surgical instrument manufacturers with the maximum power for a cordless surgical device. The sterilization of rechargeable lithium-ion batteries with hydrogen peroxide gas enables hospitals to utilize a popular sterilization process while providing surgeons with the most power for their surgical tools.

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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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Wright Medical Group, Inc. has announced the commercial launch of the XPANSION(R) Micrografting System for split-thickness skin grafting via a minimized donor site. The XPANSION(R) System is a single-use disposable instrument kit for harvesting, expanding, and applying split-thickness skin micro-autografts for the treatment of chronic and acute wounds. The current standard of care for skin grafting procedures is usually performed in the operating room under general anesthesia.

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American company Ethicon Endo-Surgery (EES) has launched two surgical staplers aimed at boosting efficiency and compression during open surgery. These two devices are the newest arrivals in the surgical instruments specialists’ range of colorectal surgery equipment. The Ethicon Endo-Surgery Linear Cutter 55/75, designed with new staple technology and variable staple heights in a single cartridge, offers improved haemostasis for patients and greater efficiency for nurses and health managers as well as surgeons.

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