No modification of this equipment is allowed. o The Indigo catheters vary in diameters from 3.4Fr to 12Fr. In particular, the Indigo catheters vary from 3 to 8 Fenabling the operator to remove thrombus from small vessels such as the pedal arch but also from large vessels such as the aorta or iliac arteries, due to the circumferential aspiration from the tip shapes offered in CAT8. Figure 1. In addition to Lightning 12, the Indigo System also now includes Lightning 8 which combines the Indigo System CAT 8 Aspiration Catheter with Lightning Intelligent Aspiration for the removal of fresh, soft emboli and thrombi from the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. We gained access through the right CFV using a 14-F sheath. doi: 10.1111/j.1525-139X.2012.01104.x. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. COURSE OF TREATMENT. Ask the Experts: How Do You Treat (and Avoid) Recurrent Varicose Veins? Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower extremities, including below the knee. Professor, FIU Herbert Wertheim College Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. The INDIGO SEPARATOR is not intended for use as a guidewire. Low-dose tPA was dripped into the left and right lobes of the PA. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. LIGHTNING Aspiration Tubing Indication for Use New Indigo System By Penumbra - Medical Device News Magazine Cat 12 is a large-lumen aspiration catheter that incorporates laser-cut hypotube-based catheter to provide deliverability and torqueability within the body. Placing guidewire too distal in the pulmonary vasculature or excessive manipulation of aspiration/ guiding catheter in the smaller, peripheral, and segmental pulmonary artery branches can result in vessel perforation. INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Lightning 12 combines the Indigo System CAT 12 Aspiration Catheter with Lightning Intelligent Aspiration, enabling physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. The Indigo Aspiration System, along with the Penumbra ENGINE and Indigo CAT8, provide a frontline treatment option for PE patients that can lower on-table PA pressures and reduce RV/LV ratios by 27.3%, per their investigational device exemption trial, EXTRACT-PE.1 The trial and our case experience at the University of Minnesota with CAT8 show that sustained aspiration with the Indigo System can provide safe mechanical relief in the treatment of PE. Warnings/Precautions The canister is intended for single use only. Lightning 12 and Separator 12 Now Indicated for Treatment of PE, The Indigo Aspiration System Lightning 12 received FDA clearance for the treatment of pulmonary embolism. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Lightning was hooked up to the Indigo System Catheter CAT12 and placed into the access sheath. At discharge, there have been no adverse device events, and clinical success at 1 month (defined as the absence of death and limb loss) is 98.6%.4. D. Chris Metzger, MD Only use replacement fuse with correct rating (see Table 1 for fuse rating). investors@penumbrainc.com INDIGO SEPARATOR 4 is intended to be used with INDIGO CAT RX Aspiration Catheter to clear the distal end of the catheter lumen should it be blocked with thrombus. Disclosures: None. The Indigo System Lightning 12 (Penumbra, Inc.) is an intelligent aspiration system powered by the Penumbra ENGINE (Figure 1). Advancement of the CAT8 and CAT6 through the popliteal and tibial arteries (A, B). University of Minnesota Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. As PE treatment options continue to grow, the EXTRACT-PE results with the Indigo System serve as a promising data set in helping move the PE landscape forward. Chief of Vascular Surgery The clot detection algorithm paired with the audiovisual cues lets the physician know when the catheter is in thrombus versus when it is in blood. Contraindications There are no contraindications. Media Relations: Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 inches (30 cm) to any part of the PENUMBRA ENGINE. At Penumbra, I have a profound opportunity to change the course of healthcare delivery for people living with vascular disease. In the current treatment of PE, standard treatments such as anticoagulation, thrombolysis, and open embolectomy have limitations. The wire was removed, and the CAT8 was used to remove thrombus from the popliteal artery. Disclosures: None. Created with Sketch. Except for historical information, certain statements in this press release are forward-looking in nature and are subject to risks, uncertainties and assumptions about us.

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