Dek Z, Strube H, Sadeghi-Azandaryani M, et al. Immediately postprocedure, a decrease in PA pressure from 35 to 27 mm Hg was observed. Low-dose tPA was dripped into the left and right lobes of the PA. Created with Sketch. Created with Sketch. The patients echocardiogram showed normal RV size and function. 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. Penumbra, the Penumbra P logo, Indigo, CAT, Separator, Lightning, and Penumbra ENGINE are trademarks of Penumbra, Inc. For more information, visit www.penumbrainc.com and connect on Twitter and LinkedIn. doi: 10.1161/CIR.0000000000000707. Contraindications There are no known contraindications. Penumbra, Inc. Do not use in an oxygen rich environment. 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. University of Siena Use only water-based solvents for cleaning. Created with Sketch. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. The wire test was done once again in the left leg, showing poor flow, a BTK clot, and evidence of chronicity. If the cause cannot be determined, withdraw the device or system as a unit. Associate Clinical Professor, University of South Florida College of Medicine All Rights Reserved Privacy Policy. Prior to use, please refer to Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events and detailed instructions for use. No modification of this equipment is allowed. Heart disease and stroke statistics2020 update: a report from the American Heart Association. Percutaneous manual thromboaspiration was the first technique proposed, followed by a series of percutaneous mechanical thrombectomy devices based on a different mechanism of action (mechanical fragmentation, aspiration, rheolytic thrombectomy, and their combinations). Do not reuse. Figure 2. Thrombolysis is not a universal option for all patient groups, especially if the patient has an absolute or relative contraindication to a fibrinolytic agent. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Risk Information. 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. Regarding the Chief Scientific and Medical Officer appointments, the company advised that Dr. Teigen joins Penumbra immediately and will contribute his extensive scientific and clinical expertise to ongoing and future research and development efforts. Figure 1. This website is intended for US audience only. The means of mains disconnect is to remove the power cord. Factors that could cause actual results to differ from those projected include, but are not limited to: the impact of the COVID-19 pandemic on our business, results of operations and financial condition; failure to sustain or grow profitability or generate positive cash flows; failure to effectively introduce and market new products; delays in product introductions; significant competition; inability to further penetrate our current customer base, expand our user base and increase the frequency of use of our products by our customers; inability to achieve or maintain satisfactory pricing and margins; manufacturing difficulties; permanent write-downs or write-offs of our inventory; product defects or failures; unfavorable outcomes in clinical trials; inability to maintain our culture as we grow; fluctuations in foreign currency exchange rates; and potential adverse regulatory actions. IVUS image showing May-Thurner narrowing of the left CIV and thrombus in the iliac vein. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Dr. Arko is chief, Division of Vascular and Endovascular Surgery, Sanger Heart and Vascular Institute in Charlotte, North Carolina. 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. 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. Large-bore embolectomy, when paired with a syringe, has led to variable results, with questions regarding the ideal technique to achieve a uniform state of vacuum aspiration.1 The catheters used to aspirate should ideally be atraumatic and easily deliverable to be able to access and establish flow through the lobar branches of the pulmonary artery (PA), reducing right heart strain and PA pressure. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Mentors and Protgs: Conversations on Career and Craft With Alda L. Tam, MD, MBA, FRCPC, FSIR, FACR, The Patient Voice in Chronic Venous Disease Treatment: What We Have and Whats Coming Next, With Kathleen Gibson, MD, FACS, FAVLS, DABVLM; Al Compaan; and Manj Gohel, MBChB, MD, FRCS, FEBVS. 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. 2021 Nov 1;48(5):e217571. Aspiration may also be performed in conjunction with an Indigo System Separator (Penumbra, Inc.) to allow for constant clearing of thrombus from the lumen of the catheter. Indigo, now with Lightning, utilizes a unique mechanism of action to help optimize thrombus removal procedures by differentiating between thrombus and blood. Blood clots in the lungs can block the lungs from absorbing oxygen, causing strain on the heart and other organs. CAT12 is . Investor Relations: INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use 4 min read. Prior to use, please refer to the . Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. The decision was made to proceed with mechanical thrombectomy. 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. Maintain a constant infusion of appropriate flush solution. July 14, 2020P enumbra, Inc. announced the United States commercial availability of the Indigo System Lightning 12, which is the company's next-generation aspiration system for peripheral thrombectomy.. 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. Las Vegas, Nevada Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM 310-560-8176. Thomas S. Maldonado, MD With Ramona Gupta, MD, FSIR; Suman M. Wasan, MD, MS, FSVM; and Avianne Bunnell, MD, RPVI, By Andres Schanzer, MD, FACS, and Stphan Haulon, MD, PhD, By Dominique Fabre, MD, PhD; Thomas J. Postiglione, MD; and Stphan Haulon, MD, PhD, Unmet Needs in Ascending and Arch Disease, With Tilo Klbel, MD, PhD, and Joseph Bavaria, MD, With Giovanni Pratesi, MD; Martina Bastianon, MD; Sara Di Gregorio, MD; Gaddiel Mozzetta, MD; and Kimberly Malka, MD, PhD, With Tim Resch, MD, PhD; Sara L. Zettervall, MD, MPH; and Carlos Timaran, MD. With contributions from Edoardo Pasqui, MD; Carlo Setacci, MD; and Giancarlo Palasciano, MD, Surgical management of lower extremity acute limb ischemia (ALI) has been considered the preferred treatment for years. In this next phase, Penumbra is set to broaden its reach on a global scale, and I am thrilled to join this excellent team and help accelerate the impact of its products.. Potential adverse . Only use replacement fuse with correct rating (see Table 1 for fuse rating). The patients right leg was completely cold, insensate, and immobile from the thigh down. 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. (Credit: Business Wire.) Any forward-looking statements are based on our current expectations, estimates and assumptions regarding future events and are applicable only as of the dates of such statements. 4. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. The Indigo System with Lightning Intelligent Aspiration is available in the United States in the following configurations: Lightning 12, Lightning 8 and Lightning 7. 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. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Fluoroscopy showed additional thrombus in the tibioperoneal trunk (TPT) (, Final fluoroscopy of the left leg showed restored distal runoff (. COURSE OF TREATMENT. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Figure 3. Created with Sketch. Media Relations: Penumbra continues to lead the field of clot management by bringing highly innovative technology to address the challenges that we as physicians face while caring for our patients, commented Frank Arko, MD, in the company's announcement. It will reduce the service life of the PENUMBRA ENGINE. 1. 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. Director of Interventional Radiology When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. All Rights Reserved Privacy Policy, 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; D. Chris Metzger, MD, Robert Lookstein, MD, MHCDL, FSIR, FAHA, FSVM. An intuitive clicking sound is made by the device that signals that one is in free-flowing blood. right-arrow Figure 1. The system is indicated for the removal of fresh, soft emboli and thrombi . The on-table PA pressures were statistically reduced, and the median device time was 37 minutes. 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. Diagn Interv Radiol. 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. To ensure the most secure and best overall experience on our website we recommend the latest versions of, Internet Explorer is no longer supported. Penumbra, Inc. This combination of intelligent aspiration and large-lumen catheter engineering makes Lightning 12 Penumbras most advanced clot removal technology for the treatment of pulmonary embolism. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Stainless steel hypotube; Large lumen size and circumferential sweep enables maximized thrombus engagement; Determining and Applying Appropriate Use of Venous Care, With Kathleen Ozsvath, MD, and Elna Masuda, MD, left-arrow Equipment is not safe for MR use. CAT12 is a large . Vessel patency is assessed using the thrombolysis in myocardial infarction (TIMI) score classifications, both before and after the use of the device. The catheters, which were initially designed for intracranial navigation for the treatment of acute stroke, are provided with an atraumatic tip. of Medicine The means of mains disconnect is to remove the power cord. Venogram showing thrombosis of the left FV and CFV. Penumbra, a global healthcare company, has secured the expanded US Food and Drug Administration 510 (k) approval for the new generation of its Indigo Aspiration System, Lightning 12. Lightning 12: 12 F (4.04 mm) HTORQ (100 cm, 115 cm lengths) XTORQ (100 cm length) Lightning 7: 7 F (2.3 mm) XTORQ (130 cm length) CAT . INDIGO CAT RX Aspiration Catheters and INDIGO SEPARATOR 4 Indication for Use As part of the INDIGO Aspiration System, the INDIGO CAT RX Aspiration Catheters and INDIGO SEPARATOR 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. Contraindications There are no contraindications. Co-Director, Aortic Institute 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. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. If the cause cannot be determined, withdraw the device or system as a unit. The system designed to reduce blood loss and the need for clot-dissolving drugs, which . 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. The INDIGO SEPARATOR is not intended for use as a guidewire. PENUMBRA ENGINE Indication for Use Disclosures: None. 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. CAT 12 is a . Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Poor flow through the left TPT. The Indigo CAT12 represents an advancement in mechanical thrombectomy given its ability to aspirate large-volume thrombus in a single-session setting, which is especially beneficial in larger-lumen vascular beds, such as large-caliber veins as demonstrated in this case. Preprocedural CT of the patients left pulmonary anatomy. Do not use kinked or damaged devices. Executive Vice Chairman Engineered to be trackable, deliverable, and torqueable, the CAT8s atraumatic tip can navigate the lobar anatomy of the PA to help establish inflow and outflow, helping to restore patient vitals to normal. Miami Cardiac and Vascular Institute Learn more about Lightning. lee lakosky bow setup, protestant reformed church split 2021,
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