Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. 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 . If the cause cannot be determined, withdraw the device or system as a unit. 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. If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. Final angiogram with complete TIMI 3 flow after the use of CAT RX. A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. The Penumbra ENGINE addresses the limitations of traditional treatment options by providing sustained mechanical power aspiration for the duration of the procedure to help maximize efficiency of thrombus removal. . After IVUS, the stent was dilated to 3.75 mm. 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. Device Name. PENUMBRA: CAT6 - WestCMR The penumbra cat8 indigo system (cat8) was kinked approximately 4. Do not use automated high-pressure contrast injection equipment with the INDIGO CAT RX 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. Penumbra, a US-based provider of advanced therapies, has enrolled the first patient into the CHEETAH clinical study, designed to evaluate the safety and performance of the Indigo System with CAT RX Aspiration Catheter in the coronary vessels. Do not use in oxygen rich environment. Mathews SJ, Brown C, Kolski B, et al. St. Joseph Hospital Cedars Sinai Medical Center There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. Categories. function gtag(){dataLayer.push(arguments);} 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 System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral and venous systems, and certain central circulatory systems conditions such as pulmonary emboli, using continuous aspiration. Contraindications There are no contraindications. If repositioning of the INDIGO CAT RX Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard guidewire techniques. Saxon RR, Benenati JF, Teigen C, et al. Penumbra's CAT family of catheters is engineered to be robust, trackable, atraumatic, and well suited to the peripheral anatomy where clots can form in long segments. Throughout each case, Lightning provides procedural feedback via audio visual cues. Angiography was performed and confirmed complete thrombus removal and flow restoration through the SVG. UPC: Current Stock: This item is out of stock. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 8 She had a recent embolic cerebrovascular accident (CVA) with a hemorrhagic conversion and right-sided hemiparesis but was otherwise known to be very functional. 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. INDIGO Aspiration System Intended Use Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. This content is not intended to offer professional medical advice. 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. Indigo System Intended Use CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral Thrombectomy Mechanical one eachCAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm , 8Fr., Peripheral . Next Article . Do not use kinked or damaged devices. The CAT family of catheters is the foundation of Penumbra's Indigo System. Only use replacement fuse with correct rating (see Table 1 for fuse rating). 1.10 Summary of Non-Clinical Data As required under Section 12, Part (a)(i)(3A) of the Safe Medical Devices Act of 1990, a The CAT family of catheters is the foundation of Penumbra's Indigo system. indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. CAT7 and CAT12 are the next generation of the Indigo System catheters. Contraindications There are no known contraindications. 0, 24. kolskiwellness@gmail.com The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). Penumbra's CAT family of catheters is engineered to be robust, trackable, atraumatic, and well suited to the peripheral anatomy where clots can form in long segments. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. 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 Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. Learn more about Lightning. CAT7 and CAT12 are the next generation of the Indigo System Catheters. Do not use open or damaged packages. 3. Figure 2. Do not use kinked or damaged devices. Separator 8, 150 cm Length, 0.072 in. 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. Director of Cardiac Catheterization Lab, PERT & Structural Heart The Penumbra CAT RX catheter was used in a total of 34 patients, with 71% STEMI, 23% NSTEMI, 3% UA, and 3% new onset heart failure. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. Innovation in Coronary Mechanical Thrombectomy: Indigo System CAT RX Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. PDF May 15, 2018 - Food And Drug Administration Possible complications include, but are not limited to, the following: Related Items. Do not reuse. The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) based on the risk of unexpected death or serious . Do not use kinked or damaged devices. IN-DATE. With S. Jay Mathews, MD, MS, FACC; Chris Metzger, MD; Waqas R. Qureshi, MD, MS; Jawairia Sahar K. Mirza, MBBS; Gus Theodos, MD, FACC, FSCAI; Brian Kolski, MD; and Suhail Dohad, MD, FACC. Figure 1. In patients with submassive pulmonary embolism with compromised right ventricular function and elevated biomarkers, the Indigo System is an excellent frontline tool offering a safe and effective1 treatment option. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. PENUMBRA: SEP8 - Westcmr.com These data are encouraging and have led to the next stage in data collection through the CHEETAH studya 400-patient, prospective, observational study evaluating the initial safety and performance of the Indigo Aspiration System CAT RX. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Indigo System CAT RX | Penumbra Inc Disclosures: Consultant to Penumbra, Inc. An 83-year-old woman transferred from an outside hospital presented with acute shortness of breath, was hypotensive, and was intubated. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. Figure 3. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. The procedure was completed with the same catheter. Do not use kinked or damaged devices. As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator 4 (Penumbra, Inc.) are indicated for the removal of fresh soft emboli and thrombi from vessels in the coronary and peripheral vasculature. 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. Maintain a constant infusion of appropriate flush solution. The complaint has been evaluated. In some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). This case illustrates the vast improvement in aspiration technology with an easy-to-deliver, trackable catheter that maintains sustained aspiration for the duration of the procedure. Indigo System - Vascupedia 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. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. 0, 26. The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 Due to our experience in such cases, sustained aspiration with the Indigo System CAT RX with Penumbra ENGINE has quickly become our frontline device, challenging the traditional method of manual aspiration in patients with thrombi and emboli in the coronary arteries. 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. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Jawairia Sahar K. Mirza, MBBS gtag('js', new Date()); The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). Do not use in an oxygen rich environment. Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. Use only waterbased solvents for cleaning. Equipment is not safe for MR use. Additional Details. A, Penumbra Indigo System Continuous Aspiration - ResearchGate Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. 0, and 37. 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. These pages are not intended for patients or for members of the general public. 5 and 94. Use only water-based solvents for cleaning. No modification of this equipment is allowed. 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. 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. Contraindications 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. No conversations found. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. Precautions 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. Kingsport, Tennessee The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). INDIGO Aspiration System with LIGHTNING Aspiration Tubing Indication for Use TIMI 3 flow was achieved in 88% of cases. 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 advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Excessive aspiration or failure to close the Indigo Aspiration Tubing valve when aspiration is complete is not recommended. Giri J, Sista AK, Weinberg J, et al. Sista A. Indigo aspiration system for acute pulmonary embolism. Figure 2. Brian Kolski, MD Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. The catheters (CAT3, CAT RX*, CAT5, CAT6, CAT8, CATD) vary in diameters from 3.4 to 8 F and lengths of 50 to 150 cm to . 2017;377:2240-2252. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Orange, California 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. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. Created with Sketch. Penumbra ENGINE Indication For Use Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Prior to use, please consult device labeling and instructions for use. Figure 2. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Prior to use, please consult device labeling and instructions for use. Photo: Courtesy of Business Wire. Warnings/Precautions Initial angiogram showing high thrombus burden in the RCA. $399.00 EACH. This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. Do not resterilize or reuse. 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). Contraindications PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8 DXE: Back to Search Results: Model Number CAT8XTORQ115KIT-S: Device Problems Break (1069); Physical Resistance/Sticking (4012) Patient Problem No Clinical Signs, Symptoms or Conditions (4582) Event Date 05/19/2021: Potential Adverse Events Indigo System Catheters & Separators | Penumbra Inc The CAT8 is indicated for removal of emboli and thrombi from the peripheral . Penumbra, Inc. One Penumbra Place. In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon Figure 2. 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. The means of mains disconnect is to remove the power cord. Pela bainha, foi introduzido o dispositivo de aspirao Penumbra Indigo System CAT8 XTORQ (Penumbra Inc., Alameda, Califrnia, Estados Unidos) em trombo segmentar, lobar ou arterial pulmonar principal, sendo realizada aspirao contnua (Figuras 2 e 3). 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. Ultrasound-guided access was obtained through the right femoral vein. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). The Indigo SystemCAT3, CAT5, CAT6, CAT8, CATD, and CAT RX are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. 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. Unit may overheat and shut off or fail to restart if run for extended periods without airflow. Engineered with neuro-tracking technology, CAT RX is designed to navigate tortuous anatomy and track to distal coronary vasculature while maintaining sustained mechanical aspiration with the Penumbra ENGINE. Pulmonary artery peak pressures dropped from the mid 40s to the high 30s. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. 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. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. 2015;372:1389-1398. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. QUICK VIEW. Chris Metzger, MD CHEETAH will focus on patients presenting with high-grade thrombus burden who receive frontline treatment with CAT RX. 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. SVG occlusions can be challenging to resolve using traditional treatment modalities. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. Previous Article, Single-Access Technique for Impella-Assisted High-Risk PCI. Mechanical Thrombectomy | Medical Billing and Coding Forum - AAPC left-arrow To prevent fire or shock hazard, use a replacement power cord of equal rating. Ballad CVA Heart & Vascular Institute How Penumbra's smart-sucking algorithms and catheters speed up clot Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. The Indigo System utilizes the Penumbra ENGINEaspiration source capable of delivering nearly pure, continuous vacuum to our catheters to remove thrombus in vessels of various sizes. Figure 2. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). Penumbra aspiration assistance | Medical Billing and Coding Forum - AAPC Mechanical Aspiration Thrombectomy Using the Penumbra CAT RX - PubMed window.dataLayer = window.dataLayer || []; After one pass with mechanical thrombectomy using CAT RX, the thrombus was removed and flow was restored to the pedal arch via the plantar posterior tibial artery (Figure 2 and Figure 3). Indication For Use Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. University of Massachusetts Medical School Use prior to the Use By date. Bradenton Cardiology Center/Manatee Memorial Hospital 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. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. Do not re-infuse blood or fluid from the canister back into the patient. The product-specific content of this website is intended for use by healthcare professionals only. 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 CAT family of catheters is the foundation of Penumbra's Indigo system. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. 8: Add BMK6F95M-NE . 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 in the presence of a flammable anesthetic mixture with air or nitrous oxide. The INDIGO SEPARATOR is not intended for use as a guidewire. Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: . CAT8XTORQ115KIT-NS. These pages are not intended for patients or for members of the general public. The system uses Penumbra's RED reperfusion catheters. UPC: Current Stock: . J Am Coll Cardiol. She had acute tubular necrosis with minimal urine output at the time of transfer. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Mechanical power aspiration with the Indigo System CAT RX (Penumbra, Inc.), introduced in 2018, continues to gain in popularity as a solution for high thrombus burden in the coronaries. Final angiogram showing resolution of extensive thrombus burden. Penumbra Indigo Aspiration System IDE Trial for Acute Pulmonary Penumbra System ACE 68 KIT Reperfusion Catheter & Penumbra Hi-Flow Aspiration Tubing - 6Fr x .068" x 132cm: 6Fr x .068" x 132cm $600.00. Waqas R. Qureshi, MD, MS Use prior to the Use By date. At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. Do not use open or damaged packages. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. 1. Return all damaged devices and packaging to the manufacturer/distributor. The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. Disclosures: Consultant to Penumbra, Inc. A 59-year-old man with a history of hypertension and tobacco use presented with an inferior-posterior acute myocardial infarction (MI). Distal OD. The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Available in a selection of sizes, the CAT family can enable access to distal peripheral vessels of the upper and lower extremities, including below the knee. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. 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. Smidt Heart institute 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. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. We directly stented with a 3.5- X 38-mm Synergy DES and postdilated with a 4- X 20-mm noncompliant balloon. The initial angiogram revealed TIMI 0 flow in the proximal right coronary artery (RCA) due to plaque rupture. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. 5, 19. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. The product-specific content of this website is intended for use by healthcare professionals only. Distal emboli causing PDA occlusion after manual aspiration. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. 1. 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. Possible complications include, but are not limited to, the following: acute vessel occlusion; air embolism; allergic reaction and anaphylaxis from contrast media or device material; anemia; arrhythmia; arteriovenous fistula; cardiac injury, cardiac perforation, cardiac tamponade; cardio-respiratory arrest; compartment syndrome; death; emboli; emergent surgery; foreign body embolization; hematoma or hemorrhage at access site; hemoptysis; hemorrhage; hypotension/hypertension; infarction leading to organ damage; infection; ischemia; myocardial infarction; neurological deficits including stroke; pneumothorax; pseudoaneurysm; renal impairment or acute renal failure from contrast media; residual thrombus due to inability to completely remove thrombus or control blood flow; respiratory failure; valvular damage; vessel spasm, thrombosis, dissection (intimal disruption), or perforation.
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