CHEETAH will focus on patients presenting with high-grade thrombus burden who receive frontline treatment with CAT RX. Do not use in oxygen rich environment. Categories. 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 . Los Angeles, California
University of Massachusetts Medical School
Randomized trial of primary PCI with or without routine manual thrombectomy. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. The CAT family of catheters is the foundation of Penumbras Indigo System. Alameda, CA 94502. 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. 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. Manual aspiration using a Pronto V3 (Teleflex) catheter restored some flow, however, distal embolization to the posterior descending artery (PDA) immediately caused right ventricular cardiac arrest (Figure 2). Penumbra ENGINE Intended Use excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this . Penumbra, Inc. One Penumbra Place. INDIGO Aspiration System Intended Use 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. CAT7 and CAT12 are the next generation of the Indigo System catheters. Do not resterilize or reuse. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. Suhail Dohad, MD, FACC
Potential Adverse Events 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. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Next Article If the cause cannot be determined, withdraw the device or system as a unit. At our institutions, we are using CAT RX for patients who present with fresh soft thrombi or emboli. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). Pulmonary artery peak pressures dropped from the mid 40s to the high 30s. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. Further evaluation of the returned device revealed kinks in the catheter shaft. 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. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Hemoglobin and hematocrit levels should be monitored in patients with >700 mL blood loss from the clot aspiration procedure. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATDare engineered to be robust, durable, and trackable for use in the peripheral anatomy. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. 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. Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . Return all damaged devices and packaging to the manufacturer/distributor. Do not use open or damaged packages. Available in a selection of sizes, the CAT family can provide access to distal peripheral . Figure 2. Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. 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. 1. Conclusions: evaluation of the cat8 revealed that the device was fractured. function gtag(){dataLayer.push(arguments);} Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. The Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. There were no cases of 30-day cardiovascular death or post procedural stroke. The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Do not re-infuse blood or fluid from the canister back into the patient. 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. Brian Kolski, MD
Sista A. Indigo aspiration system for acute pulmonary embolism. Latest System Designed for Single Session Arterial Thrombus Removal News An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. Bradenton Cardiology Center/Manatee Memorial Hospital
Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Photo: Courtesy of Business Wire. If the cause cannot be determined, withdraw the device or system as a unit. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. 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. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Indigo System | Computer-Aided Mechanical Aspiration. Use only water-based solvents for cleaning. A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). 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. Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 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. Mathews SJ, Brown C, Kolski B, et al. The removal of fibrous, adherent or calcified material (e.g. INDIGO System LIGHTNING Aspiration Tubing Intended Use Copyright 2023 Penumbra, Inc. All rights reserved. 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 . The Indigo System CAT RX was the preferred choice for mechanical aspiration thrombectomy to remove the distal emboli below the knee in the posterior tibial artery. 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. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. Cedars Sinai Medical Center
Indication For Use . A second angiogram showed extensive clot burden spread across multiple branches (Figure 2). Lightning 7 expands Penumbra's offering of the Indigo Aspiration System with Intelligent Aspiration for mechanical thrombectomy and is designed for single session arterial thrombus removal. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. The Swan-Ganz catheter was exchanged over a long V18 wire. N Engl J Med. The atraumatic tip and small catheter French size of the CAT8 device allows for easy tracking and maneuvering through the vasculature and selective debulking of thrombus from lobar branches of the pulmonary arterial tree. 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. Director, Structural Heart
The means of mains disconnect is to remove the power cord. The results may vary depending on a variety of patient specific attributes. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Penumbra's high-performance aspiration catheters. gtag('js', new Date()); Throughout each case, Lightning provides procedural feedback via audio visual cues. . The Indigo Aspiration System is contraindicated in: When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. No conversations found. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. (CAT3, CAT RX, CAT5, CAT6, CAT8, and CATD) and patented Separator technology, which maintains continuous aspiration and helps limit clogging of the catheters tip during the procedure. Return all damaged devices and packaging to the manufacturer/distributor. 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 Created with Sketch. The newest indication for the Indigo System is the treatment of pulmonary embolism; this indication comes on the heels of the promising results of the EXTRACT-PE trial. 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. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Copyright 2022 Penumbra, Inc. All rights reserved. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. 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. window.dataLayer = window.dataLayer || []; Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. Indigo System CAT RX tracking through the distal posterior tibial artery. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. This content is not intended to offer professional medical advice. The cerebral vasculature Distal OD, Sterile, Single-Use, Disposable, For CAT8 Penumbra Devices, Indigo Aspiration Catheters, Removal of Fresh, Soft Emboli and Thrombi from Vessels of Peripheral Arterial and Venous Systems If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. 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. 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. It will reduce service life of the Penumbra ENGINE. The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Distal emboli causing PDA occlusion after manual aspiration. 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. Indigo Aspiration System Intended Use Do not use open or damaged packages. With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. Final angiogram after stent placement showing resolution of underlying disease. Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE. 510 (k) Number. 2: Add After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. minimalism: a documentary about the important things transcript; cat8 penumbra catheter; i 75 road construction cincinnati; tocaya west hollywood; best places to live in alabama near the. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . 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 the PENUMBRA ENGINE. Warnings These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. kolskiwellness@gmail.com
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 . Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Do not resterilize or reuse. UPC: Current Stock: . 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. The Indigo System CAT RX with Penumbra ENGINE is an invaluable tool that is easy to set up and can provide rapid thrombectomy and immediate reperfusion. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. These types of burns heal withing 5 or 6 days without permanent scarring. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. Penumbra's LANTERN Delivery Microcatheter integrates a highly trackable 2.6 F microcatheter with a high-flow lumen to facilitate confident delivery of Ruby Coil, POD, and Packing Coil even in tortuous anatomy. St. Joseph Hospital
Equipment is not safe for MR use. Jolly SS, Cairns JA, Yusuf S, et al. Launches Indigo System Lightning 12 in U.S. Appoints Corey L. Teigen, M.D., as Chief Scientific Officer and James F. Benenati, M.D., FSIR, as Chief Medical Officer Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced its next phase for vascular franchise growth with U.S. commercial availability of the Indigo System Lightning 12 and . Vedantham S, Goldhaber SZ, Julian JA, et al. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . Final angiographic result of SVG. CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. Figure 1. Maintain a constant infusion of appropriate flush solution. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. Control angiography immediately after thrombectomy demonstrated restored patency . In some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. 5, 19. 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. function gtag(){dataLayer.push(arguments);} In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. 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. 22. Indigo System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration.