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Penumbra Indigo System | Vascular Thrombectomy 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). Figure 1. Lightning enables clot detection so the physician knows when the catheter is in thrombus and when it is in patent flow. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Precautions The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Perspectives on PE Care Using Penumbra's Indigo System With Lightning Figure 8. Blood clots in the lungs can block the lungs from absorbing oxygen, causing strain on the heart and other organs. Poor distal runoff from acute thrombus. The Indigo CAT8 XTORQ was advanced over the select catheter and used in both the right and left PAs. Disclosures: None. Patrick E. Muck, MD, RVT, FACS In my radiology practice, Ive seen firsthand the challenges medical practitioners face while treating difficult medical conditions, stated Dr. Teigen in the announcement. The Indigo System aspiration catheter is available in a range of lengths and diameters that, when connected to the proprietary Penumbra Aspiration Pump, may help atraumatically remove the thrombus under continuous aspiration. Penumbra's Newest Generation of Indigo Aspiration System Receives FDA When in free-flowing blood, this technology automatically stops aspirating blood and hence limits unnecessary loss of blood. Schwartz-Buckley Professor of Surgery, Vascular Division If the cause cannot be determined, withdraw the device or system as a unit. Do not reuse. 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. 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. Manhattan Veterans Administration Hospital 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. From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event. The reasons have been mainly related to the limited trackability, the risk of vessel injury, and/or the incidence of incomplete revascularization, and the risk of bleeding and hemolysis.2,3. The patients left leg was cool to the touch with signs of paresthesia but with motor function still intact. Penumbras IndigoAspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for treatment of pulmonary embolism. 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. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Now, the goal with thrombus removal in PE is to safely and effectively remove thrombus and potentially reduce treatment time. LIGHTNING Aspiration Tubing Indication for Use The EXTRACT-PE study completed in 2019 evaluated the safety and efficacy of the Indigo Aspiration System in the management of submassive PE. Contraindications Not for use in the coronaries or the neurovasculature. Do not use kinked or damaged devices. 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 . The major adverse event rate in EXTRACT-PE was 1.7%, and patients had a median intensive care unit stay of < 1 day. 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. The Next Generation of Thrombus Removal | Penumbra Inc Do not resterilize or reuse. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. 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 LIGHTNING Aspiration Tubing. Contraindications There are no known contraindications. Access was gained using an 8-F sheath in the left popliteal vein, which was then upsized to a 12-F sheath. By capturing the clot without maceration and under high aspiration power, the risk for distal emboli may be minimized. 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. A wire test was conducted in the right leg to determine the composition of the clot. Indigo System - Vascupedia FDA Clears Penumbra's Lightning 12 Aspiration Catheter for Pulmonary Chief of Vascular Surgery 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. The device is intended for single use only. Dr. Arko is chief, Division of Vascular and Endovascular Surgery, Sanger Heart and Vascular Institute in Charlotte, North Carolina. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. Figure 3. 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. Created with Sketch. The Indigo System Lightning 12 is the companys newest generation aspiration system for peripheral thrombectomy. Use prior to the Use By date. Do not use in oxygen rich environment. In PE cases, patients are often emergent and need interventions that provide immediate relief. Heart disease and stroke statistics2020 update: a report from the American Heart Association. 12 F Laser Cut Hypotube Catheter. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. February 2022. Use prior to the Use By date. The wire was removed, and the CAT8 was used to remove thrombus from the popliteal artery. Thomas S. Maldonado, MD When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Circulation. Penumbra's Indigo System With Lightning Intelligent Aspiration The Indigo Aspiration System is comprised of several devices: The Indigo System is used as a first-line approach or rescue therapy for arterial and venous thrombotic events. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Created with Sketch. Mechanical Thrombectomy of Pulmonary Emboli With Use of the Indigo The Penumbra Indigo System Separator is intended for use with our Indigo System's CAT family of catheters to enable the removal of a wide range of thrombus. The patient, an active smoker, also had a history of pulmonary hypertension and hypercholesterolemia. The audiovisual cues from Lightning and the thrombus detection algorithm enabled us to navigate the lobar branches of the PA. Lightnings audio cues, in the form of clicking, help with clot detection to optimize thrombus removal and focus on the screen rather than monitor flow through the tubing and canister. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. When the catheter is engaged on thrombus or embolic material, the clicking sound ceases. Created with Sketch. IVUS image showing a widely patent lumen after thrombectomy and stenting. STRIDE is currently ongoing. Mean PA pressure at the start of the case was 35 mm Hg. 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. 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 combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. More recently, a number of other endovascular mechanical thrombectomy devices have been introduced as treatment options; however, many physicians still rely on adjunctive tPA, either to lace the thrombus at time of procedure or postoperatively via an in-dwelling lytic catheter. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. The Lightning 12 addition to the Indigo Aspiration System is a formative development in the thrombectomy space. No modification of this equipment is allowed. 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. Lightning Intelligent Aspiration allows physicians to optimize the thrombus removal needed to complete venous thrombus procedures that would otherwise be more complicated. Maintain a constant infusion of appropriate flush solution. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. University of Minnesota Miami Cancer Institute To prevent fire or shock hazard, use a replacement power cord of equal rating. Of note, the patient was not a good candidate for thrombolysis due to retroperitoneal hemorrhage from lymph node biopsy several days earlier. Image of thrombus aspirated using the Indigo CAT12 Aspiration Catheter. Lightning has also demonstrated an 18:1 potential fluid loss savings during bench top testing when used versus the Dynamic Aspiration Tubing. Otherwise, this could result in degradation of the performance of this equipment. Associate Professor of Vascular Surgery The Next Generation of Thrombus Removal | Penumbra Inc 5. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. 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. Penumbra, Inc. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. The Indigo System has demonstrated high rates of revascularization with consistent success. Lightning 12. Vessel patency is assessed using the thrombolysis in myocardial infarction (TIMI) score classifications, both before and after the use of the device. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. 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. 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 (. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. Figure 1. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. A 67-year-old woman with a history of venous thrombus and iliac venous stenting presented with significant recurrent left lower extremity venous thrombus, and the patients symptoms did not significantly improve with anticoagulation alone. Created with Sketch. Sista A. Penumbra has changed the landscape of healthcare by providing truly innovative solutions for a wide realm of medical challenges. 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. Precautions The device is intended or single use only. 2020;141(9):e139e596. Risk Information. The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. New York, New York Penumbra Announces the European Launch of the Indigo System With Lightning is paired with CAT8 or CAT12. INDIGO Aspiration System with LIGHTNING Aspiration Tubing - Indication for Use . Miami Vascular Specialists Figure 1 shows a popliteal aneurysm with massive endoluminal thrombosis and distal multilevel embolism in the tibial and plantar arteries. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Massive intravascular hemolysis with mechanical rheolytic thrombectomy of a hemodialysis arteriovenous fistula. of Medicine When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Preprocedural CT of the patients left pulmonary anatomy. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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. The patients right leg was completely cold, insensate, and immobile from the thigh down. chronic clot, atherosclerotic plaque) The cerebral vasculature Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Postprocedural CT of the patients left pulmonary anatomy. The INDIGO SEPARATOR is not intended for use as a guidewire. The new Indigo System is engineered to allow for thrombectomy while helping to prevent excessive blood loss during the procedure. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. Next Article 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. Kingsport, Tennessee Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Precautions The device is intended for single use only. Only use replacement fuse with correct rating (see Table 1 for fuse rating). The Indigo System with Lightning Intelligent Aspiration and Separators is indicated for the removal of fresh, soft emboli and thrombi from the peripheral arterial and venous . As part of the Indigo Aspiration System, Lightning 12 (Indigo System CAT 12 Aspiration Catheter with Lightning Intelligent Aspiration) and Separator 12 are now indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems as well as for the treatment of pulmonary embolism. 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 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. Do not use in an oxygen rich environment. STRIDE is the newest study from Penumbra evaluating the removal of thrombus with the Indigo Aspiration System in patients with lower extremity ALI. Previous Article, Biotronik's Dynetic-35 Iliac Stent Launched in Europe. Do not block bottom air vents. The Indigo Aspiration System Lightning 12 granted FDA approval. The catheters, which were initially designed for intracranial navigation for the treatment of acute stroke, are provided with an atraumatic tip. Program Director, Vascular Fellowship & Integrated Residency This allows the operator to focus on the procedure and not on the canister. right-arrow MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12 QEW Thrombolysis is not a universal option for all patient groups, especially if the patient has an absolute or relative contraindication to a fibrinolytic agent. . A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Our business and operations are subject to a variety of risks and uncertainties and, consequently, actual results may differ materially from those projected by any forward-looking statements. If the cause cannot be determined, withdraw the device or system as a unit. INDIGO Aspiration System Indication for Use Otherwise, this could result in degradation of the performance of this equipment. Precautions The device is intended or single use only. Lightning 12 Intelligent Aspiration. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. The Indigo System has been designed to address the limitations of traditional treatment options. CAT12 is a large-lumen aspiration catheter that incorporates novel laser-cut hypotube-based catheter engineering to provide advanced deliverability and torqueability within the body. 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. rosen011@umn.edu The on-table PA pressures were statistically reduced, and the median device time was 37 minutes. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. The acute pulmonary embolism (PE) treatment paradigm is evolving to treat patients that have emergent symptoms and are unable to tolerate long thromboaspiration procedures. Return all damaged devices and packaging to the manufacturer/distributor. 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 . Catheters & Separators. 2014;59:729-36. A 47-year-old woman with no previous history of thromboembolism presented with sudden-onset PE. Ballad Health System CVA Heart & Vascular Institute Disclosures: None. Michael S. Rosenberg, MD, FSIR, FACR Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. 1. J Vasc Surg. To gain access into the lobar branches, a 5-F, 125-cm vertebral catheter over a 0.035-inch stiff, angled Glidewire (Terumo Interventional Systems) was used. The Indigo System Lightning 12 is the company's newest generation aspiration system for peripheral thrombectomy. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX Aspiration Catheter because it may damage the device. The results may not be predictive of all patients. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Single-session management of PE using the Indigo System CAT8 allows physicians to treat emergent patients. Ripal T. Gandhi, MD, FSIR, FSVM However, these hybrid procedures include the invasiveness of open surgery and carry the risk of incomplete thrombus removal or vessel damage.1, Consequently, many new endovascular devices have been proposed to increase treatment success, decrease complications, and rapidly improve perfusion. Return all damaged devices and packaging to the manufacturer/ distributor. Warnings/Precautions The canister is intended for single use only. Figure 6. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. The 1:1 torqueability of the catheter was especially valuable for aspirating thrombus along the circumference of the larger-diameter iliac veins.

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