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Home » Regulatory roundup: Cook Medical wins FDA approval for two renal stents

Regulatory roundup: Cook Medical wins FDA approval for two renal stents

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Clearances roundup

Here’s a roundup of companies announcing clearances and approvals from the Food & Drug Administration and foreign regulatory agencies:

  • Cook Medical Receives FDA Approval for Two Renal Stents
    Cook Medical received premarket approval (PMA) from the FDA for its Formula™ Balloon-Expandable Renal Stent System. The approval includes both the Formula 414RX Balloon Expandable Renal Stent and the Formula 418 Balloon Expandable Renal Stent. As stated in its approval letter, the FDA has said these devices are indicated for use in patients with atherosclerotic disease of the renal arteries following suboptimal percutaneous transluminal renal angioplasty (PTRA) of de novo or restenotic lesions.
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  • Spectranetics Receives FDA Approval for Site Change Related to Manufacturing of CVX-300® Laser System
    Spectranetics Corporation (NSDQ:SPNC) announced that the FDA has approved the Company’s premarket approval application (PMA) supplement requesting a manufacturing site change for the CVX-300® laser system. The move of laser system manufacturing from its current location in Colorado Springs, Colorado is part of a broader plan to consolidate all product manufacturing into a single, more efficiently designed facility following rapid expansion of the Company’s business within the last five years, a period in which revenue has nearly tripled. The employees involved in the manufacturing of laser systems will move to the new manufacturing site, which is also located in Colorado Springs and further serves as corporate headquarters.
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  • Winner Medical Obtains Cotton Processing Certificate from the State Development and Reform Commission
    Winner Medical Group Inc. (NSDQ:WWIN), (“Winner Medical”) a leading manufacturer of medical dressings, medical disposables and non-woven fabric made from 100% natural PurCotton® products in China, announced that one of its subsidiaries, Huanggang Winner Cotton Co., Ltd., (“Huanggang Cotton”), was recently awarded a Cotton Processing Certificate by the State Development and Reform Commission.
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  • CASMED Receives FDA Clearance for Non-Cerebral Indication of FORE-SIGHT Absolute Tissue Oximeter
    CAS Medical Systems, Inc. (NSDQ:CASM) announced receipt of 510(k) clearance from the FDA for expanded labeling of its FORE-SIGHT® Absolute Tissue Oximeter to monitor skeletal muscle of infants, children and adolescents weighing between 5 and 50 kg.
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  • Palomar Offers New Skin Rejuvenation Platform and Announces the First FDA Clearance for Combination Fractional Resurfacing
    Palomar Medical Technologies, Inc., a leading researcher and developer of lasers and pulsed-light systems for aesthetic treatments, is pleased to announce that the Artisan(TM) Aesthetic System is now being shipped. The Artisan provides a combined fractional ablative and fractional non-ablative laser skin resurfacing treatment — the first approach of this kind to receive clearance by the United States FDA.
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  • EKOS Corporation Receives CE Mark to Treat Massive and Sub-Massive Pulmonary Embolism
    EKOS Corporation announced the EKOS EkoSonic® Endovascular System is the first endovascular device approved for the treatment of pulmonary embolism (PE). The EkoSonic® System, which was originally designed and approved to dissolve blood clots in the arms and legs, now has the added indication for treating this major unmet medical need.
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  • AdvanDx Receives FDA 510(k) Clearance for GNR Traffic Light(TM) PNA FISH(R)
    AdvanDx announced that it has received FDA 510(k) clearance for its GNR Traffic Light(TM) PNA FISH(R) test. GNR Traffic Light PNA FISH is the first test capable of simultaneously identifying Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa directly from positive blood cultures containing Gram-negative rods in less than 90 minutes. The test is the latest addition to AdvanDx’s easy-to-use, molecular-based PNA FISH diagnostics platform designed to provide rapid, therapy-guiding results that enable clinicians to provide early, effective therapy for patients with Gram-negative bloodstream infections (BSI).
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  • Gore Receives Health Canada Approval for Removable GORE® VIABIL® Biliary Endoprosthesis
    W. L. Gore & Associates, Inc. (Gore) announced it has received approval from Health Canada for the Removable GORE VIABIL Biliary Endoprosthesis. This device is designed for the treatment of benign or malignant biliary strictures followed by optional removal up to 12 months after implantation. The Removable GORE VIABIL Biliary Endoprosthesis is the only fully covered, self expanding biliary stent in the world that offers a strong, durable barrier against tumor ingrowth and tissue attachment with anti-migration fin technology, thereby making it ideal for treating benign and malignant strictures in the biliary tree.
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  • Atrium and Kaneka Launch Xpress-Way™ RX Extraction Catheter in the U.S.
    Atrium Medical Corporation and Kaneka Corporation are proud to announce the introduction of the Xpress-Way™ RX Extraction Catheter. Xpress-Way RX has recently received FDA 510K clearance and is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. The Xpress-Way RX manual extraction catheter is manufactured by Kaneka Corporation (Osaka, Japan) and Atrium Medical Corporation (Hudson, NH) is the exclusive distributor of the Xpress-Way RX in the U.S.
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  • Vitrolife Obtains CE Mark for Product for Freeze Storage of Sperm.
    SpermFreeze Solution™, which is used for freeze storage of sperm, has obtained a CE mark and is thereby approved for sales within the European Economic Area (EEA). The freezing of sperm is used in connection with IVF treatment for patients who find it difficult to produce sperm samples or who are diagnosed as having cancer. In order to be able to become parents, these patients are completely dependent on the sperm surviving and functioning after freezing and thawing.
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  • Wright Medical Group, Inc. Announces Launch of DARCO® Foot & Ankle Plating Line in Japan
    Wright Medical Group, Inc. (NSDQ:WMGI), a global orthopaedic medical device company, announced the launch of the DARCO® Foot & Ankle Plating System in Japan. The DARCO® Plating System consists of over 40 different locked plates specifically designed to meet the needs of foot and ankle surgeons. Wright has been selling the DARCO® Plating System in the United States and other key global markets since 2007.
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  • Wright Medical Group, Inc. Announces IDE Approval for Calcaneal Stem Fixation for the INBONE® Total Ankle System
    Wright Medical announced that it has received approval from the FDA to conduct an Investigational Device Exemption (IDE) clinical study to investigate use of the INBONE® Total Ankle Replacement with Calcaneal Stem for treatment of end stage ankle arthritis or revision of a failed ankle replacement with subtalar joint insufficiency.
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  • Nfocus Neuromedical Announces FDA 510(k) Clearance for Next Generation Device to Treat Vascular Lesions
    Nfocus Neuromedical, Inc., an innovative medical device company with a focus on the next generation treatment for brain aneurysms, announced that the company received FDA 510(k) clearance for its Acta™ Vessel Occlusion System (VOS). The Acta VOS provides physicians with a minimally-invasive alternative to current treatment options for an array of common and potentially serious vascular lesions.
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  • IntraPace Receives CE Mark Certification for the abiliti® System for the Treatment of Obesity
    IntraPace, Inc., announced that it has received European CE Mark approval for the abiliti system as a treatment for obesity. The CE Mark certifies that a product has met European Union requirements for commercial marketing in Europe.
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  • Stereotaxis Announces CE Mark and First Human Case for Vdrive™
    Stereotaxis, Inc. (NSDQ:STXS) announces the first successful cardiac ablation procedure with the Vdrive™ robotic navigation system as the company received CE Mark for this latest innovation. In the first procedure with the Vdrive system, Tamas Szili-Torok, MD, Ph.D., from the Department of Clinical Electrophysiology at the Erasmus Medical Center in The Netherlands, successfully treated atrial fibrillation in a patient with known difficult heart anatomy. Dr. Szili-Torok was able to complete the entire case without having to manually adjust the circular mapping catheter.
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