The Indigo System met its efficacy and safety endpoints by reducing right-to-left ventricle (RV/LV) ratio at 48 hours by 27.3% (mean ratio reduction, 0.43; 95% confidence interval, 0.380.47; P < .0001) and had a low major adverse event of 1.7% (2/119). Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . 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. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. System Chair, Clinical Research 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. The deliverability and continuous aspiration power were essential to achieving restoration of flow supporting a positive patient outcome to help heal this case of CLI. Aspiration Tubing Intended Use Penumbra Cat 8 - IndiaMART We decided to start with mechanical aspiration using CAT RX and Penumbra ENGINE to extract the thrombus. 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. UMassMemorial University Campus The patient underwent six shocks and was intubated while CAT RX was delivered through the freshly placed 3.5- X 38-mm DES to the PDA. PDF May 15, 2018 - Food And Drug Administration 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. Waqas R. Qureshi, MD, MS 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. 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. The pulmonary capillary wedge pressure is 10 mmHg. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. 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. Due to continual vomiting, an electrocardiogram was obtained that showed an acute MI. Each vessel was wired sequentially, delivering power aspiration via CAT RX to the site of each thrombus. Final angiogram showing resolution of extensive thrombus burden. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. 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. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. The CAT family of catheters is the foundation of Penumbra's Indigo system. Penumbra ENGINE Intended Use If the device is forcefully retracted at extreme angles during removal from the packaging, damage such as this may occur. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Do not use open or damaged packages. 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. 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. Do not resterilize or reuse. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Do not use open or damaged packages. 2019;140:e774-e801. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Contraindications There are no known contraindications. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . IN-DATE. Precautions The device is intended for single use only. These pages are not intended for patients or for members of the general public. In some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). 3. TIMI 3 flow was achieved in 88% of cases. A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. No modification of this equipment is allowed. Photo: Courtesy of Business Wire. This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. Initial angiography revealed an occlusion of the distal RCA. Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm gtag('js', new Date()); Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: . No conversations found. The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. Additional Details. Learn more about Lightning. 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. Interventional Cardiology 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 . Lightning Flash: The Most Powerful and Advanced Mechanical Initial angiogram showing high thrombus burden in the left circumflex artery. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CAT7 and CAT12 are the next generation of the Indigo System Catheters. Conclusions: evaluation of the cat8 revealed that the device was fractured. Penumbra ENGINE Indication For Use Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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. With automatic valve control, Lightning can help the physician focus on optimizing thrombus removal procedures. 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. Do not use kinked or damaged devices. Smidt Heart institute 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. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F(x) CAT RX has allowed us to rethink how we approach these occluded SVGs. 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. 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. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Gus Theodos, MD, FACC, FSCAI
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