o Self-Contained & Disposable: Fully self-contained, single-use device with no need for capital equipment purchase
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1 The ClariVein OC Proprietary dual action device^ ClariVein OC is a specialty catheter for the infusion of physician-specified agents in the peripheral vasculature including for endovascular occlusion of incompetent veins in patients with superficial venous reflux. The ClariVein OC is fully disposable, minimally invasive, and can be efficiently used in an office setting. ClariVein OC offers many patient benefits including minimal postoperative pain and faster recovery 1. Introduced through a microintroducer set, infusion is through an opening at the distal end of the catheter and fluid is delivered by use of a rotating wire and dispersion tip^. Motor Drive Unit: Drives the wire rotation. o Self-Contained & Disposable: Fully self-contained, single-use device with no need for capital equipment purchase o Power System: The Motor Drive Unit is operated by a low voltage, self-contained power system o Variable Rotating Speed: Multiple speed settings allow for rotating wire and dispersion ball to rotate between approximately 2,000 and 3,500 RPM o Single-Handed Operation: Motor Drive Unit designed to be fully operational with one hand Catheter Assembly: The catheter is easily identified under vascular imaging and incorporates a cartridge for secure fastening to the Motor Drive Unit. o Ease of Navigation o Small Profile: < 3 French Infusion Catheter o Flexibility: Multiple catheter lengths available. Navigatable catheter based on patient anatomy and desired tip location o Flexible: coaxial catheter with rotating wire and a dispersion ball at the distal tip o Marked: Conveniently marked catheter shaft allows for accurate pullback and infusion o Excellent Visualization: Rotating wire and dispersion ball easily identified under imaging guidance o Cartridge Attachment: Designed for secure fastening to Motor Drive Unit Indications For Use: The ClariVein OC is indicated for infusion of physician-specified agents in the peripheral vasculature including for endovascular occlusion of incompetent veins in patients with superficial venous reflux. Labeling: Refer to product labeling provided with each product for Description, Directions for Use, Warnings, Precautions and Potential Complications/Adverse Effects. 1. D. Boersma, et al., Mechanochemical Endovenous Ablation of Small Saphenous Vein Insufficiency Using the ClariVein Device: One-year Results of a Prospective Series, European Journal of Vascular and Endovascular Surgery, Volume 45 Issue 3 March/2013, p Vascular Insights LLC, 1 Pine Hill Drive, Two Batterymarch Park, Suite 100, Quincy, MA 02169, USA M-013 (R3) ClariVein and Vascular Insights are registered trademarks of Vascular Insights in the United States.
2 Using The ClariVein OC Dispersion Wire Tip 1. ClariVein OC is introduced percutaneously into the peripheral vasculature under imaging guidance*. The dispersion wire tip is easy to visualize for accurate placement in the treatment zone^. 2. The Catheter Assembly is connected to the Motor Drive Unit (MDU). 3. The MDU rotates the wire and dispersion tip allowing for targeted infusion of the physicianspecified agents to the treatment zone. 4. Patients often return to their normal activities immediately post-operative. Indications For Use: The ClariVein OC is indicated for infusion of physician-specified agents in the peripheral vasculature including for endovascular occlusion of incompetent veins in patients with superficial venous reflux. Labeling: Refer to product labeling provided with each product for Description, Directions for Use, Warnings, Precautions and Potential Complications/Adverse Effects. * Including Ultrasound Vascular Insights LLC, 1 Pine Hill Drive, Two Batterymarch Park, Suite 100, Quincy, MA 02169, USA M-012 (R3) ClariVein and Vascular Insights are registered trademarks of Vascular Insights in the United States.
3 The ClariVein OC Advantage With more than 60,000 units in the market*, the ClariVein OC device is designed to benefit patients and physicians alike. Advantages: Physician Patient MINIMALLY INVASIVE^ FAST PROCEDURE TIME^ QUICK RETURN TO RMAL ACTIVITIES^ MINIMIZES PATIENT DISCOMFORT^ PERFORMED IN AN OFFICE SETTING^ Tumescentless procedure decreases procedure time^ CONTAINS phthalate MATERIALS^ Self-contained disposable Device^ REDUCED COST: USER SERVICEABLE PARTS^ Indications For Use: The ClariVein OC is indicated for infusion of physician-specified agents in the peripheral vasculature including for endovascular occlusion of incompetent veins in patients with superficial venous reflux. Labeling: Refer to product labeling provided with each product for Description, Directions for Use, Warnings, Precautions and Potential Complications/Adverse Effects. *The ClariVein family of infusion catheters distributed worldwide. Vascular Insights LLC, 1 Pine Hill Drive, Two Batterymarch Park, Suite 100, Quincy, MA 02169, USA M-011 (R3) ClariVein and Vascular Insights are registered trademarks of Vascular Insights in the United States.
4 ClariVein OC * Versus Radiofrequency Postoperative pain and early quality of life after radiofrequency ablation and mechanochemical endovenous ablation of incompetent great saphenous veins 1 *When using ClariVein OC for the MOCA procedure and physician-specified agents for the treatment of incompetent veins with superficial venous reflux MOCA RFA MOCA RFA MOCA RFA Improvement Identical Deterioration Fig 1. Assesment of the Venous Clinical Severity Score (VCSS) 6 weeks after the treatment with mechanochemical endovenous ablation (MOCA) and radiofrequency ablation (RFA). This study has demonstrated that postoperative pain is significantly lower after MOCA compared with RFA, corresponding to a 74% reduction in pain for the first 14 postoperative days 1. The time to return to normal activities was 1.0 day (IQR, 0-1.0) in the MOCA group and 1.0 day (IQR, ) in the RFA group, which was significantly longer (P=.01) 1. Mean VAS Score ( 0-100mm) Up to 74% reduction with MOCA RFA MOCA The median time to work resumption for employees was significantly shorter in the MOCA group than in the RFA group (P=.02), respectively, 1.0 days (IQR, ) vs 2.0 days (IQR, ) Time (Days) Error bars: 95% CI Fig 2. Mean postoperative pain scores on a 0 to 100 mm visual analogue scale for 14 days after mechanochemical endovenous ablation (MOCA) and radiofrequency ablation (RFA). CI, Confidence interval; VAS, visual analog scale. Indications For Use: The ClariVein OC is indicated for infusion of physician-specified agents in the peripheral vasculature including for endovascular occlusion of incompetent veins in patients with superficial venous reflux. Labeling: Refer to product provided with each product for Description, Directions for Use, Warnings, Precautions and Potential Complications/Adverse Effects. 1. R. van Eekeren, et al., Postoperative Pain and Early Quality of Life After Radiofrequency Ablation and Mechanochemical Endovenous Ablation of Incompetent Great Saphenous Veins, Journal of Vascular Surgery, Volume 57, Number 2, February 2013, p *Results of one clinical study may not be indicative of all clinical experiences. Vascular Insights LLC, 1 Pine Hill Drive, Two Batterymarch Park, Suite 100, Quincy, MA 02169, USA M-015 (R3) ClariVein and Vascular Insights are registered trademarks of Vascular Insights in the United States.
5 ClariVein OC * Comparison to Thermal Ablation for Treatment of Incompetent Veins due to Superficial Venous Reflux Thermal Ablation No 6 FR or larger GSV & SSV -May not be suited for smaller vessels due to thermal damage risk 1 Risk from thermal energy 2 Requires Tumescent Anesthesia Requires Sclerosing Agent * Risk of Thermal Damage Nerves Skin Paresthesia Percutaneous Access Capital Equipment Investment Lease Agreement Contract Purchasing Equipment Maintenance Contract Treatment Suitability Patient Pain & Bruising Image Visualization ClariVein OC YES 4 fr or Larger^ GSV & SSV -Plus small vessels all the way to ankle. Some studies show success in the venous ulcer beds 2 74% less post-operative pain 1 less bruising RF: Park and Wait Laser: 1.5mm / second Pullback Timing & Method 1-3mm / second * When using ClariVein OC for the delivery of sclerosant. Refer to sclerosant labeling for important information. Indications For Use: The ClariVein OC is indicated for infusion of physician-specified agents in the peripheral vasculature including for endovascular occlusion of incompetent veins in patients with superficial venous reflux. Labeling: Refer to product provided with each product for Description, Directions for Use, Warnings, Precautions and Potential Complications/Adverse Effects. ^ Data on File 1. R. van Eekeren, et al., Postoperative Pain and Early Quality of Life After Radiofrequency Ablation and Mechanochemical Endovenous Ablation of Incompetent Great Saphenous Veins, Journal of Vascular Surgery, Volume 57, Number 2, February 2013, p Hayley M Moore, Tristan RA Lane, Ian J Franklin and Alun H Davies Retrograde Mechanochemical Ablation of the Small Saphenous Vein for the Treatment of a Venous Ulcer first published December 17, 2013 Vascular Insights LLC, 1 Pine Hill Drive, Two Batterymarch Park, Suite 100, Quincy, MA 02169, USA M-016 (R3) ClariVein and Vascular Insights are registered trademarks of Vascular Insights in the United States.
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