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. Mechanical thrombectomy was performed. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. The treatment of arterial and venous thrombus is challenging. Categories. The patient had a robust recovery and was discharged to her rehab facility on anticoagulation. window.dataLayer = window.dataLayer || []; Figure 2. The removal of fibrous, adherent or calcified material (e.g. 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. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. Penumbra ENGINE Intended Use Do not use in an oxygen rich environment. 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. Indication For Use This content is not intended to offer professional medical advice. 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. The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007.
MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION 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. Chris Metzger, MD
0, and 37. 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 some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). If the cause cannot be determined, withdraw the device or system as a unit. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. 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. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Power aspiration with CAT RX has allowed us to successfully remove thrombus in patients presenting with acute coronary syndrome, establishing quick distal reperfusion and also visualization of the underlying stenosis.
Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F(x) University of Massachusetts Medical School
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. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. The procedure can be performed quickly,1 which is important for symptomatic patients. 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. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. When performing aspiration, ensure that the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. 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. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. Disclosures: Consultant to Penumbra, Inc. A 75-year-old woman with a history of diabetes, hypertension, and dyslipidemia presented with Rutherford class 5 critical limb ischemia (CLI) due to a nonhealing ulcer. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. 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. 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.
Catheters - Aspiration Catheters - Page 1 - Medical Materials Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. Next Article 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). Latest System Designed for Single Session Arterial Thrombus Removal News The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). 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. Disclosures: None. 1. gtag('js', new Date());
Penumbra Augments Vascular Franchise with Latest Indigo System Launch 5 and 94. Do not use in oxygen rich environment. A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). Use prior to the Use By date. Contraindications There are no known contraindications. Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. The Indigo System CAT RX and Penumbra ENGINE aspiration source were crucial to the success of this case. Learn more about Lightning. 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. 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 . Worcester, Massachusetts
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 . The product-specific content of this website is intended for use by healthcare professionals only. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. The INDIGO SEPARATOR is not intended for use as a guidewire. It will reduce service life of the Penumbra ENGINE. The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. The Swan-Ganz catheter was exchanged over a long V18 wire. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. Potential Adverse Events 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. Do not reuse. Return all damaged devices and packaging to the manufacturer/distributor. Saint Louis, Missouri
Possible complications include, but are not limited to, the following:
Penumbra enrols first patient in CHEETAH Study of Indigo CAT RX device The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy.
skin is red but turns white when pressed Do not resterilize or reuse. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Cardiac Interventions Today (ISSN 2572-5955 print and ISSN 2572-5963 online) is a publication dedicated to providing coverage of the latest developments in technology, techniques, clinical studies, and regulatory and reimbursement issues in the field of coronary and cardiac interventions. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. window.dataLayer = window.dataLayer || []; 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. The means of mains disconnect is to remove the power cord. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. Mathews SJ, Brown C, Kolski B, et al.
The Indigo System and CAT8 - Endovascular Today PENUMBRA ENGINE Intended Use The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Return all damaged devices and packaging to the manufacturer/distributor. Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Missouri Baptist Medical Center
. 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. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). 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 kinked or damaged devices. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. System Chair, Clinical Research
There was partial improvement of flow, but total occlusion remained. The patient remained on cangrelor with no need for tirofiban. $399.00 EACH. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. The large aspiration lumen and highly trackable, low-profile design coupled with the power of the Penumbra ENGINE resulted in the successful removal of the emboli in one pass. 2018;29:92-100. 3. The procedure was completed with the same catheter. The INDIGO Aspiration Tubing:
Indigo System CAT RX | Penumbra Inc Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. . 510 (k) Number. Final angiogram with complete TIMI 3 flow after the use of CAT RX. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Distal OD. Prior to use, please consult device labeling and instructions for use. UPC: Current Stock: . Created with Sketch. Mechanical Thrombectomy. This website is intended for US audience only. Warnings Return all damaged devices and packaging to the manufacturer/distributor. Ultrasound-guided access was obtained through the right femoral vein. The PENUMBRA ENGINE is intended as a vacuum source for Penumbra Aspiration Systems.
Indigo System Catheters & Separators | Penumbra Inc Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Figure 1. Warnings
A, Penumbra Indigo System Continuous Aspiration - ResearchGate To prevent fire or shock hazard, use a replacement power cord of equal rating.
Innovation in Coronary Mechanical Thrombectomy: Indigo System CAT RX The device is intended for single use only. SVG occlusions can be challenging to resolve using traditional treatment modalities. function gtag(){dataLayer.push(arguments);} 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. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Do not use open or damaged packages. 5, 21. The Indigo System with Lightning Aspiration Tubing is an intelligent aspiration system powered by Penumbra ENGINE. Brian Kolski, MD
The low-profile catheter and Penumbra . Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. Brandenton, Florida
CAT RX is an essential tool in our percutaneous coronary armamentarium. Final angiogram showing resolution of extensive thrombus burden. INDIGO Aspiration Tubing: Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System.
CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing 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. Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. 0 cm from the distal tip. 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. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. gtag('js', new Date()); Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Saxon RR, Benenati JF, Teigen C, et al. 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. Final angiographic result of SVG. Maintain a constant infusion of appropriate flush solution. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. Vedantham S, Goldhaber SZ, Julian JA, et al. An 8-French 45 cm Destination sheath was placed to the main pulmonary artery. Copyright 2022 Penumbra, Inc. All rights reserved. This has allowed expansion of the use of the Indigo System in patients with coronary and peripheral vascular thrombotic occlusions. The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. 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; arteriovenous fistula; cardiac injury; cardio-respiratory arrest; death; device malfunction; distal embolization; emboli; excessive blood loss; 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; hemoptysis; respiratory failure; thromboembolic events.
CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Because the patient was not a candidate for thrombolysis, the decision was made to intervene with the Indigo System CAT8XTORQ115 and SEP 8, which were advanced sequentially into the right then left pulmonary artery. Potential Adverse Events 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. Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. This site is protected by reCAPTCHA and the Google, Mechanical clot engagement with proprietary Separator technology, Tip directionality for circumferential aspiration, The Indigo System is an integrated system for use only with other components of the Indigo System including the CAT family of catheters, Separators, Dynamic Aspiration Tubing, Lightning, Penumbra ENGINE, and Penumbra ENGINE Canister, Lightning Intelligent Aspiration comes packaged with CAT7, CAT8 or CAT12, Live feedback during the procedure with integrated clot catcher, Penumbra ENGINE is capable of delivering and maintaining nearly pure vacuum (-29 inHg or 98.2 kPa) with the disposable Penumbra ENGINE Canister. 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.
Contraindications Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. She was in a rehab facility prior to this new event recovering from her CVA. Use prior to the Use By date. Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. Throughout each case, Lightning provides procedural feedback via audiovisual cues. Do not use Indigo Separator 4 to macerate or retrieve thrombus distal to the catheter tip. Most recently, Penumbra launched Lightning Intelligent Aspiration which enables physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism.