indigo system lightning 12

INDIGO Aspiration System with LIGHTNING Aspiration Tubing - Indication for Use . Poor distal runoff from acute thrombus. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. The goal of this study is to create a prospective multicenter study that provides safety and performance data on the Indigo System as a frontline percutaneous aspiration thrombectomy approach for ALI patients for whom immediate treatment and revascularization can maintain limb viability. Icahn School of Medicine at Mount Sinai Designed for single session arterial thrombus removal, New angled tip shape for maximized clot extraction, Dual pressure sensors for real-time flow monitoring, Large lumen size and circumferential sweep enables maximized thrombus engagement, Multi-pitch hypotube for 1:1 torque transfer and advanced deliverability, Indicated for the treatment of pulmonary embolism. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12 QEW Miami Cancer Institute Lightning 12 combines the Indigo System CAT12 Aspiration Catheter with . Endovascular Today (ISSN 1551-1944 print and ISSN 2689-792X online) is a publication dedicated to bringing you comprehensive coverage of all the latest technology, techniques, and developments in the endovascular field. Do not resterilize or reuse. A 0.014-inch wire was used to track to the occlusion, and the Indigo System CAT6 was used to aspirate the clot (. CT revealed that the patient had a bilateral PE with an elevated RV/LV ratio of 2.26, an elevated troponin level of 0.151 g/mL, and PA pressures at 35 mm Hg. The fundamental components of the Lightning 12 Intelligent Aspiration system are the Engine pump, the Lightning control unit, and the CAT 12 HTORQ 12F catheter. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Dr. Arko continued, "When dealing with thrombus, we have learned that it is the combination of the catheter along with powered aspiration that yields the most effective results. Do not use kinked or damaged devices. INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. The on-table PA pressures were statistically reduced, and the median device time was 37 minutes. Contraindications There are no contraindications. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. The 1:1 torqueability of the catheter was especially valuable for aspirating thrombus along the circumference of the larger-diameter iliac veins. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Lightning enables clot detection so the physician knows when the catheter is in thrombus and when it is in patent flow. Preprocedural CT of the patients left pulmonary anatomy. The Indigo Aspiration System with Lightning 12 removes these difficult-to-access, life-threatening clots, potentially reducing the need for thrombolytics and their associated ICU stays. Use prior to the Use By date. INDIGO Aspiration Catheters and Separators: As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. Dr. Benenati will join Penumbra on September 1, 2020, and will contribute to clinical and medical affairs strategies and advise upon global commercialization and market development activities. To prevent fire or shock hazard, use a replacement power cord of equal rating. Indigo, now with Lightning, utilizes a unique mechanism of action to help optimize thrombus removal procedures by differentiating between thrombus and blood. These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2019 filed with the SEC on February 26, 2020, our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 filed with the SEC on May 7, 2020, our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 filed with the SEC on August 3, 2020, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 filed with the SEC on November 2, 2020. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. This website is intended for US audience only. Penumbra Announces the European Launch of the Indigo System With The Indigo CAT12 Aspiration Catheter is indicated for removal of fresh, soft emboli and thrombi from vessels of the peripheral venous systems. Internet Explorer presents a security risk. on behalf of the American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. July 14, 2020Penumbra, Inc. announced the United States commercial availability of the Indigo System Lightning 12, which is the companys next-generation aspiration system for peripheral thrombectomy. Return all damaged devices and packaging to the manufacturer/ distributor. Do not use open or damaged packages. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. It will reduce the service life of the PENUMBRA ENGINE. Do not resterilize or reuse. Good Samaritan Hospital Immediately postprocedure, a decrease in PA pressure from 35 to 27 mm Hg was observed. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Michael S. Rosenberg, MD, FSIR, FACR 12 F Laser Cut Hypotube Catheter. Penumbra's newest generation of Indigo aspiration system receives FDA The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. Investor Relations: Penumbra Augments Vascular Franchise with Latest Indigo System Launch PENUMBRA ENGINE Indication for Use Penumbra Announces the European Launch of the Indigo System With Gianmarco de Donato, MD Penumbra designs, develops, manufactures and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. A venogram was performed via left popliteal vein access, which demonstrated thrombosis of the left femoral vein (FV) and common femoral vein (CFV) (Figure 1) and the previously stented left common iliac vein (CIV) and external iliac vein (EIV) (Figure 2). This allows the operator to focus on the procedure and not on the canister. Betsy Merryman Created with Sketch. Immediately after, Lightning with the Indigo System Catheter CAT8 was used to aspirate thrombus in the left PA (, Due to increased amounts of thrombus in the right lobe, the SEP8 was introduced to clear the lumen of the catheter (. Eur J Vasc Endovasc Surg. Localization of the thrombus was quite variable in our cohort of patients, although in the majority of cases (67%), patients presented with thrombus in the popliteal or BTK vessels. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Otherwise, this could result in degradation of the performance of this equipment. Patrick E. Muck, MD, RVT, FACS The catheters, which were initially designed for intracranial navigation for the treatment of acute stroke, are provided with an atraumatic tip. Penumbra, Inc. The patients right leg was completely cold, insensate, and immobile from the thigh down. Lightning 12 combines the new Indigo System CAT12 Aspiration Catheter with Lightning Intelligent Aspiration, enabling physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism . We performed a transjugular access with a 12-F introducer sheath. The Indigo System Lightning 12 is the company's next generation aspiration system for peripheral thrombectomy. The patient also had a history of bilateral PE dating back to October 2017, at which point rivaroxaban was prescribed. 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. Low-dose tPA was dripped into the left and right lobes of the PA. It will reduce the service life of the PENUMBRA ENGINE. Do not use open or damaged packages. Computer-Aided Thrombus Removal Using Penumbra's Lightning 7 and Penumbra also announced appointments for two newly created positions: Corey L. Teigen, MD, as Chief Scientific Officer and James F. Benenati, MD, as Chief Medical Officer. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Scan showing preoperative left venous thrombus. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Do not resterilize or reuse. 2. Potential Adverse Events Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arrhythmia/fibrillation; arteriovenous fistula; death; device malfunction; distal embolization; emergent surgery; false aneurysm formation; hematoma, hemorrhage, or blood loss at access site; hematoma, hemorrhage, or blood loss; hypotension; inability to completely remove thrombus or control blood flow; infection; ischemia; kidney damage from contrast media; myocardial infarction; neurological deficits including stroke; respiratory failure; thromboembolic events; vascular complications (including vessel spasm, thrombosis, intimal disruption, dissection, or perforation). With Frank R. Arko III, MD; Patrick E. Muck, MD, RVT, FACS; Ripal T. Gandhi, MD, FSIR, FSVM; Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM; Michael S. Rosenberg, MD, FSIR, FACR; Eric Moldestad, MD; Gianmarco de Donato, MD; Thomas S. Maldonado, MD; and D. Chris Metzger, MD. The Indigo System Lightning 12 is the companys newest generation aspiration system for peripheral thrombectomy. Figure 1. Upon arrival to the hospital, physical examination and a Doppler ultrasound examination revealed absent pulses in the left foot. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Created with Sketch. The INDIGO SEPARATOR is not intended for use as a guidewire. Atrium Health Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Postprocedural CT of the patients left pulmonary anatomy. Image showing the total thrombus removed. Mean PA pressure postintervention was 21 mm Hg. Utility of a power aspiration-based extraction technique as an initial and secondary approach in the treatment of peripheral arterial thromboembolism: results of the multicenter PRISM trial. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The Penumbra Indigo System Separator is intended for use with our Indigo Systems CAT family of catheters to enable the removal of a wide range of thrombus. 310-560-8176. Lightning is paired with CAT8 or CAT12. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. The means of mains disconnect is to remove the power cord. Traditionally, tPA or open embolectomy were the primary treatment options for acute-to-chronic lesions. COVID has increased the awareness of the need for therapies that remove blood clots, and we are thrilled with the FDA clearance of the PE treatment indication for Lightning 12.. Veryan Medical Will Support Commercialization of Walk Vasculars Jeti Thrombectomy System in Germany, left-arrow Individual results may vary depending on patient-specific attributes. Figure 1. COURSE OF TREATMENT. 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. Desert Radiology Do not use open or damaged packages. ALAMEDA, Calif.--(BUSINESS WIRE)--Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced U.S. Food and Drug Administration 510(k) clearance for expanded indication of the latest iteration of the Indigo Aspiration System, Lightning 12. 2023 Bryn Mawr Communications II, LLC. The wire was removed, and the CAT8 was used to remove thrombus from the popliteal artery. If the cause cannot be determined, withdraw the device or system as a unit. Miami Vascular Specialists Angiography after Indigo power aspiration and popliteal aneurysm repair with a stent graft (Viabahn, Gore & Associates) revealed a patency of the tibial (A) and plantar (B) vessels. Disclosures: None. 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. Penumbra Indigo System | Vascular Thrombectomy Do not use in oxygen rich environment. CT revealed an occlusion in the popliteal artery (Figure 1). Common emitters (such as RFID emitters, security systems, diathermy equipment, and portable transmitters) should not be used in close proximity to the PENUMBRA ENGINE as they can interfere with and result in degradation of the performance of the equipment. Created with Sketch. A 57-year-old man presented with acute-onset left calf pain for the past 10 days and had recently taken a 4-hour flight. 2014;59:729-36. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Do not resterilize or reuse. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Figure 7. The Next Generation of Thrombus Removal | Penumbra Inc The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Restored distal flow to the left TPT. Figure 3. With the severity of this patients symptoms, immediate relief was required to maintain limb viability and the different profiles of the Indigo catheters provided a complete portfolio for aspiration in the arterial vasculature, starting with the CAT8 in the SFA and BTK to using the CAT RX coaxially in the heavily diseased TPT. Intravascular ultrasound (IVUS) revealed May-Thurner syndrome, which was treated with stenting in the CIV and EIV; 100% of the clot was resolved (, The newly available Indigo CAT12 Aspiration Catheter (Penumbra, Inc.) was utilized to perform mechanical thrombectomy of the FV, CFV, and EIV and CIV without the use of thrombolytics (, Significant thrombus was aspirated from the Indigo CAT12 Aspiration Catheter (, May-Thurner narrowing of the left CIV was noted and treated with a Vici stent (Boston Scientific Corporation), with IVUS before treatment (, IVUS after thrombectomy and stenting showed a widely patent lumen (. Minneapolis, Minnesota The latest addition to the catheter line, the CAT12, is Penumbras most torqueable and trackable catheter to date. Lightning 12. 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. Presented at Vascular InterVentional Advances (VIVA) 2019; November 6, 2019; Las Vegas, Nevada. The means of mains disconnect is to remove the power cord. Do not re-infuse blood or fluid from the canister back into the patient. For more information, visit https://www.penumbrainc.com/indigo-lightning/. Prior to use, please refer to Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events and detailed instructions for use. The catheter is robust and trackable, and the large lumen allows for thrombectomy either with a guidewire in place or without a guidewire. Chief of Vascular Surgery After considering the acute onset of symptoms and the history of thrombosis, we decided to proceed with the Indigo System to treat the bilateral PE in one session. The wire test was done once again in the left leg, showing poor flow, a BTK clot, and evidence of chronicity. Sanger Heart and Vascular Institute (Credit: Business Wire.) Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Diagn Interv Radiol. Intraoperative angiography can identify any arterial imperfection after surgical thromboembolectomy, which may be corrected simultaneously by endovascular techniques. IVUS image showing a widely patent lumen after thrombectomy and stenting. The Indigo Separator is advanced and retracted through the corresponding size Indigo catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the catheter tip. Many of the first-generation mechanical endovascular devices for thrombus removal have failed to be adequately successful or have been associated with unacceptable complication rates. New York, New York Do not use kinked or damaged devices. The latest generation of Penumbras continuous aspiration thrombectomy system features Indigo System Lightning 12 which combines the new Indigo System CAT 12 Aspiration Catheter with Lightning Intelligent Aspiration powered by Penumbra ENGINE, enabling physicians to focus on optimizing thrombus removal using the systems unique clot detection mechanism. Use prior to the Use By date. In such a case, the use of multiple catheters (CAT8 for popliteal, CAT6 for tibials, and CAT3 for plantars) was particularly helpful (Figure 2 and Figure 3). Sustained aspiration from the Indigo System provides physicians with an alternative option for patients who are not ideal candidates for lytics or open embolectomy and provides a frontline therapy option that still preserves the use of any adjunctive therapy. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. Penumbra's Newest Generation of Indigo Aspiration System Receives FDA Blood clots in the lungs can block the lungs from absorbing oxygen, causing strain on the heart and other organs. The device is intended for single use only. Semin Dial. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. Lightning 12 Intelligent Aspiration | Penumbra Inc Preliminary data from the INDIAN registry is promising regarding early safety and efficacy for the revascularization of acute peripheral arterial occlusions with thromboaspiration as primary therapy. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. In addition, the RV/LV ratio decreased from 2.26 to 1.09, over a > 50% on-table decrease. Powered by the Penumbra Engine, Lightning 7 and Lightning 12 combine the new Indigo system CAT7 and CAT12 aspiration catheters with Lightning intelligent aspiration, a computer-aided clot detection technology that can differentiate between clot and blood. Do not use in oxygen rich environment. Rotational thrombectomy of acute peripheral vascular occlusions using the ThromCat XT device: techniques, indications, and initial results. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. With Lightning 8, we were able to clear the loft lobar branch and detect that we had established substantial inflow and outflow so we could move to the next affected lobe. Merryman Communications INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. In my radiology practice, Ive seen firsthand the challenges medical practitioners face while treating difficult medical conditions, stated Dr. Teigen in the announcement. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. Indigo, now with Lightning, utilizes a unique mechanism of action to help optimize thrombus removal procedures by differentiating between thrombus and blood. doi: 10.1161/CIR.0000000000000707. 1. de Donato G, Setacci F, Sirignano P, Galzerano G, Massaroni R, Setacci C. The combination of surgical embolectomy and endovascular techniques may improve outcomes of patients with acute lower limb ischemia. Do not resterilize or reuse. Lightning 12 combines the new Indigo System CAT12 Aspiration Catheter with Lightning Intelligent Aspiration, enabling physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism . New Indigo System By Penumbra - Medical Device News Magazine I feel privileged to join Penumbras unparalleled group of talented engineers and leaders, and I look forward to contributing my scientific knowledge to help solve challenging medical problems., Dr. Benenati commented, Im excited to join Penumbra at this very important time for the company, where its poised for growth, as it moves into the next generation of intelligent clot removal and expand into rehabilitation with the recent launch of the Real system. Penumbra Announces U.S. Commercial Availability of INDIGO System The Separator is specifically designed for mechanical clot engagement and is particularly helpful in acute-on-chronic thrombosis, in-stent/in-bypass fresh occlusion, and in below-the-knee (BTK) and all the way to the pedal arch thrombi localization (Figure 1).

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