Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. INDIGO Aspiration System Indication for Use Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . The Indigo System aspiration catheters are available in a range of lengths and diameters that, when connected to the Penumbra ENGINE pump, can atraumatically remove the thrombus present in various peripheral vascular beds. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. The means of mains disconnect is to remove the power cord. 510 (k) Number. Figure 2. 5, 21. Physicians in the USA have published details ofto their knowledgethe "first reported use" of the Indigo aspiration system (Penumbra) to treat cerebral venous sinus thrombosis (CVST) via endovascular thrombectomy.The treated patient underwent successful partial recanalisation of the superior sagittal sinus (SSS) and bilateral transverse sinuses (TS), and experienced . The Indigo Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems and certain central circulatory system conditions such as pulmonary emboli using continuous aspiration. Use prior to the Use By date. The procedure time was short (median of 37 minutes)the shortest demonstrated so far in an investigational device exemption (IDE) trial on patients with pulmonary embolism. She was in a rehab facility prior to this new event recovering from her CVA. Penumbra, Inc. One Penumbra Place. Director, Structural Heart If the cause cannot be determined, withdraw the device or system as a unit. Figure 3. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Manual aspiration suffers from diminished aspiration force as fluid fills in the syringe, potentially resulting in systemic embolization during catheter removal, as shown in the TOTAL trial published in 2015 (Figure 1).1 Subgroup analysis of patients with high thrombus burden was explored that highlighted the potential for improved outcomes. Maintain a constant infusion of appropriate flush solution. There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. Indication For Use Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. 22. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. She had acute tubular necrosis with minimal urine output at the time of transfer. Do not use open or damaged packages. window.dataLayer = window.dataLayer || []; excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . 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 resterilize or reuse. Figure 2. 2023 Bryn Mawr Communications II, LLC. A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). The initial angiogram revealed TIMI 0 flow in the proximal right coronary artery (RCA) due to plaque rupture. Figure 3. Return all damaged devices and packaging to the manufacturer/distributor. Using the usual telescoping technique of the sheath, the CAT8 and SEP8 were used in tandem to aspirate the thrombus using sustained aspiration with Penumbra ENGINE. The cat8 was kinked approximately 69. J Am Coll Cardiol. In some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). SVG occlusions can be challenging to resolve using traditional treatment modalities. Control angiography immediately after thrombectomy demonstrated restored patency . Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. 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. Disclosures: Consultant to Penumbra, Inc. A 92-year-old man with a history of coronary artery disease (treated previously with coronary artery bypass graft) and severe aortic stenosis (treated previously with transcatheter aortic valve replacement) presented to the ED with chest pain. Penumbra's Indigo Aspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. Units in stock: 1. 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. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Potential Adverse Events Use prior to the Use By date. Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus; Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. Medical Director, Aortic Disease and Ischemic Limb Disease 0, 24. Do not use kinked or damaged devices. The CAT8 is indicated for removal of emboli and thrombi from the peripheral . Potential Adverse Events Kingsport, Tennessee 3D, 3D Revascularization Device, ACE, Artemis, BENCHMARK, CAT, Indigo, LANTERN, Lightning, MAX, Neuron, Neuron MAX, Penumbra Coil 400, Penumbra ENGINE, Penumbra P logos, Penumbra System, Penumbra SMART COIL, POD, PX SLIM, Ruby, Select, Separator, Velocity, and WAVE are all registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. waqas.qureshi@umassmemorial.org INDIGO Aspiration System Intended Use Smidt Heart institute Resterilization and/or reuse may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target vasculature location. Otherwise, this could result in degradation of the performance of this equipment. The Indigo System Catheter CAT8 was used across 22 sites in the United States in patients with submassive PE who did not receive thrombolytics (98.3%), with a . Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 Figure 1. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. Sista A. Indigo aspiration system for acute pulmonary embolism. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. There was partial improvement of flow, but total occlusion remained. At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. Equipment is not safe for MR use. Gus Theodos, MD, FACC, FSCAI The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. Penumbra ENGINE Indication For Use Precautions Contraindications There are no known contraindications. The Penumbra P logos, 3D, 3D Revascularization Device, ACE, BENCHMARK, CAT, Indigo, LANTERN, MAX, Neuron, Neuron MAX, Penumbra ENGINE, Penumbra JET, Penumbra System, Penumbra SMART COIL, POD, Ruby, Separator, Velocity, and WAVE are registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. Saxon RR, Benenati JF, Teigen C, et al. Preprocedure TIMI 0 flow was seen in 76.3% of patients; TIMI 3 flow immediately post-CAT RX was demonstrated in 93.2% of patients. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Two passes of CAT RX with the Penumbra ENGINE resulted in TIMI 3 flow restoration and retrieval of the distal emboli from the PDA (Figure 3). Figure 2. The device is intended for single use only. Prior to use, please consult device labeling and instructions for use. Do not re-infuse blood or fluid from the canister back into the patient. CAT RX has allowed us to rethink how we approach these occluded SVGs. Use prior to the Use By date. The system uses Penumbra's RED reperfusion catheters. The low-profile catheter and Penumbra . . These pages are not intended for patients or for members of the general public. We expect the results to further refine and improve our technique for mechanical aspiration and fine-tune the use of CAT RX for patients with high thrombus burden. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Final angiogram with complete TIMI 3 flow after the use of CAT RX. The atraumatic, low-profile design of CAT RX allowed for ease of deliverability through the freshly placed stent into the PDA when the patient was in critical condition. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). There are no contraindications. We directly stented with a 3.5- X 38-mm Synergy DES and postdilated with a 4- X 20-mm noncompliant balloon. Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. Device Name. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. Prior to use, please consult device labeling and instructions for use. Vascular Thrombectomy. The complaint indicated that the cat8 was kinked during the procedure. Distal OD. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. 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. Maintain a constant infusion of appropriate flush solution. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE. Otherwise, this could result in degradation of the performance of this equipment. Ballad CVA Heart & Vascular Institute The Indigo Separator 4 is not intended for use as a guidewire. If repositioning of the INDIGO Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard catheter and guidewire techniques. Do not reuse. Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. 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. In our practice, we have been able to more accurately define percutaneous transluminal coronary angioplasty and stent length as a result of this increased visualization. This ability of lobar thrombectomy likely allowed EXTRACT-PE to be the first endovascular IDE, pulmonary embolism trial that has reported statistically significant reduction in on-table systolic pulmonary artery pressures. Do not use in oxygen rich environment. The INDIGO Aspiration System is intended to serve as a conduit to assist in thrombus removal and restoration of blood flow in the peripheral vasculature and for the treatment of pulmonary embolism. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. Do not use kinked or damaged devices. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. Pinterest; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm Penumbra System) Model #: CAT8XTORQ115KIT OEM: Penumbra System Expiration Date: 2022 Size : 8Fr x 115cm . sjaymathewsmd@gmail.com Do not resterilize or reuse. Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). left-arrow Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Vedantham S, Goldhaber SZ, Julian JA, et al. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). Mathews SJ, Brown C, Kolski B, et al. Enter your email address and we will contact you. 2015;372:1389-1398. This is potentially more effective than diminished syringe-based aspiration. Her heart rate was 110 beats per minute, elevated troponin levels at 4.5 ng/mL, and elevated brain natriuretic peptide at 1,164 pg/mL. Jolly SS, Cairns JA, Lavi S, et al. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Return all damaged devices and packaging to the manufacturer/distributor. Catheters & Separators. Final angiogram after stent placement showing resolution of underlying disease. The CAT family of catheters is the foundation of Penumbra's Indigo System. allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus; infection; hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; intimal disruption; myocardial infarction; emergent surgery; fibrillation; hypotension; respiratory failure; peripheral thromboembolic events. LIGHTNING Aspiration Tubing is a sterile aspiration tubing component of the INDIGO Aspiration System and is intended to serve as a conduit to assist in thrombus removal and restoration of blood flow in the peripheral vasculature and for the treatment of pulmonary embolism. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. If repositioning of the INDIGO Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard catheter and guidewire techniques. Maintain a constant infusion of appropriate flush solution. Further evaluation of the returned device revealed kinks in the catheter shaft. The final angiographic outcome revealed complete revascularization and TIMI 3 flow (Figure 2). S. Jay Mathews, MD, MS, FACC Disclosures: None. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. Precautions The device is intended for single use only. Caution: Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. Final angiographic result of SVG. This is potentially more effective than diminished syringe-based aspiration. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Lightning 12 and Lightning 8 expand the already broad offering of CAT8, CATD, CAT6, CAT5, and CAT3 and are paired with Penumbra ENGINE, the company's proprietary continuous, mechanical vacuum . Caution: Prior to use, please refer to the Instructions for Use for complete product indications, contraindications, warnings, precautions, potential adverse events, and detailed instructions for use. 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. The healthcare firm said that the Indigo CAT RX Aspiration Catheters . Indigo System CAT RX tracking through the distal posterior tibial artery. Otherwise, this could result in degradation of the performance of this equipment. This website is intended for US audience only. Use only water-based solvents for cleaning. 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. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Results of EXTRACT-PE Trial presented at Vascular InterVentional Advances (VIVA) Annual Meeting Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced that the EXTRACT-PE trial successfully met the primary endpoints, demonstrating the safety and efficacy of the Indigo Aspiration System for aspiration mechanical thrombectomy in patients with . Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. PENUMBRA ENGINE Indication for Use The removal of fibrous, adherent or calcified material (e.g. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. Contraindications Not for use in the coronaries or the neurovasculature. No conversations found. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Chris Metzger, MD INDIGO Aspiration System Intended Use Use prior to the Use By date. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. No modification of this equipment is allowed. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. 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. Potential Adverse Events Possible complications include, but are not limited to, the following: allergic reaction and anaphylaxis from contrast media; acute occlusion; air embolism; arteriovenous fistula; death; device malfunction; distal embolization; emboli; false aneurysm formation; hematoma or hemorrhage at access site; inability to completely remove thrombus; infection; hemorrhage; ischemia; kidney damage from contrast media; neurological deficits including stroke; vessel spasm, thrombosis, dissection, or perforation; intimal disruption; myocardial infarction; emergent surgery; fibrillation; hypotension; respiratory failure; peripheral thromboembolic events. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Disclosures: None. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System.The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Do not use open or damaged packages. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. The Indigo Aspiration System is contraindicated in: Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. Return all damaged devices and packaging to the manufacturer/ distributor. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Tip directionality for circumferential aspiration, Live feedback during procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposablePenumbra ENGINE Canister. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. With the maximized inner diameter of 0.082 and a 7 French outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. Contraindications Saint Louis, Missouri Do not resterilize or reuse. The CAT familyof catheters is the foundation of Penumbras Indigo System. With a maximised inner diameter of 0.08 (2.1 mm) and a 7 French (2.3 mm) outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. Not for use in the coronaries or the neurovasculature. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System.The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Only use replacement fuse with correct rating (see Table 1 for fuse rating). The Swan-Ganz catheter was exchanged over a long V18 wire. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Possible complications include, but are not limited to, the following: o The Penumbra Indigo System Separator is intended for use with our Indigo System's family of catheters to enable the removal of a wide range of thrombus. CAT7 and CAT12 are the next generation of the Indigo System Catheters. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. Throughout each case, Lightning provides procedural feedback via audio visual cues. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . Return all damaged devices and packaging to the manufacturer/distributor. 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 following case reports highlight CAT RX in a multitude of unique applications as a primary frontline device to treat patients with high thrombus burden. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: .

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