cat8 penumbra catheter

If the cause cannot be determined, withdraw the device or system as a unit. The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). Penumbra Indigo System | Vascular Thrombectomy Learn more about Lightning. Thrombectomy & Embolization | Vascular Medical Devices - Penumbra Inc 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 Created with Sketch. In some cases, we have also seen a reduction in glycoprotein IIb/IIIa inhibitor usage (which may be associated with higher rates of bleeding). The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 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. 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. The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. Figure 2. Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: . 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. The patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Tareq Kass-Hout. Missouri Baptist Medical Center Penumbra, CAT8XTORQ115, Penumbra CAT8 Indigo Aspiration Catheter, XTorq 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. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Contraindications 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 . The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. 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 Indigo System CAT3, CAT5, CAT6, CAT8 and CATD ?are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Saint Louis, Missouri The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. These pages are not intended for patients or for members of the general public. Jolly SS, Cairns JA, Yusuf S, et al. Copyright 2023 Penumbra, Inc. All rights reserved. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. 0, 26. CAT12 features a large 0.13 (3.33 mm) lumen and angled tip for additional circumferential sweep. 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. 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. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel. A 65-cm 8-F Destination sheath (Terumo Interventional Systems) was advanced into the right pulmonary artery, first over a telescoping balloon tip catheter and stiff angle Glidewire (Terumo Interventional Systems). 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. Possible complications include, but are not limited to, the following: Penumbra Aspiration Pump: The system uses Penumbra's RED reperfusion catheters. Use prior to the Use By date. Neuro | Penumbra, Inc. | Mechanical Thrombectomy & Embolization A repeat mechanical thrombectomy was performed of the right superficial femoral artery with flow improvement. Further evaluation of the returned device revealed kinks in the catheter shaft. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. 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. Do not use open or damaged packages. The results may vary depending on a variety of patient specific attributes. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the Penumbra ENGINE. 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. 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. This press release features multimedia. Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Penumbra CAT8TORQ85 CAT8 Indigo Aspiration Catheter 8, TORQ tip, 85cm Potential Adverse Events Potential Adverse Events Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. Initial angiogram showing high thrombus burden in the left circumflex artery. Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. Worcester, Massachusetts Potential Adverse Events This allowed prompt treatment of patients with minimal intensive care unit days and early discharge from the hospital. Do not use open or damaged packages. Presented at: Vascular InterVentional Advances (VIVA); November 47, 2019; Las Vegas, Nevada. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F(x) Contraindications Separator 8, 150 cm Length, 0.072 in. 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. 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. 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 Indigo Aspiration System IDE Trial for Acute Pulmonary Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Initial angiography revealed an occlusion of the distal RCA. gtag('js', new Date()); The Indigo System utilises the Penumbra ENGINE aspiration source capable of delivering nearly pure, continuous vacuum (-29 inHg or 98.2 kPa) to our catheters, enabling thrombus removal in vessels of various sizes. 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. The Swan-Ganz catheter was exchanged over a long V18 wire. 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. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. This content is not intended to offer professional medical advice. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. CAT12 features a large 0.131 lumen and angled tip for additional circumferential sweep. 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 Indigo System and CAT8 - Endovascular Today Final angiogram showing resolution of extensive thrombus burden. The Indigo Aspiration System is comprised of several devices: The Indigo System may be used as a first-line approach or rescue therapy for arterial and venous thrombotic events. Randomized trial of primary PCI with or without routine manual thrombectomy. Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. 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. 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: Penumbras Indigo Aspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism and/or certain central circulatory system conditions such as pulmonary emboli. left-arrow 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. window.dataLayer = window.dataLayer || []; J Vasc Interv Radiol. 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. 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. Copyright 2022 Penumbra, Inc. All rights reserved. Figure 3. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 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. 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. Do not resterilize or reuse. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Figure 1. With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. 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. Created with Sketch. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. The CAT family of catheters is the foundation of Penumbra's Indigo System. Power aspiration with CAT RX and Penumbra ENGINE was started after wiring the dominant left circumflex artery. The treatment of arterial and venous thrombus is challenging. right-arrow To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Do not block bottom air vents. No modification of this equipment is allowed. The pain became more intense and constant, so he presented to the ED. 510 (k) Number. 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. Figure 2. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. Order Qty. Penumbra System Products - Medical Materials Sista A. Indigo aspiration system for acute pulmonary embolism. 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; . She had acute tubular necrosis with minimal urine output at the time of transfer. Throughout each case, Lightning provides procedural feedback via audio visual cues. 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. 0, 24. 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. The Indigo System CAT RX and Penumbra ENGINE aspiration source were crucial to the success of this case. Use only water-based solvents for cleaning. Do not use kinked or damaged devices. St. Joseph Hospital Warnings/Precautions 2023 Bryn Mawr Communications II, LLC. Precautions The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. It will reduce the service life of the PENUMBRA ENGINE. Distal posterior tibial artery emboli occlusion. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. Not for use in the coronaries or the neurovasculature. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm After just one pass with CAT RX and 20 seconds of aspiration, the thrombus was removed. Penumbra ENGINE Indication For Use The Penumbra IndigoSystem Separatoris intended for use with our Indigo Systems CATfamily of catheters to enable the removal of a wide range of thrombus. 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. Remove and service the PENUMBRA ENGINE if liquids or solids have been drawn into the PENUMBRA ENGINE. The low-profile catheter and Penumbra ENGINE are easy to set up and use. Bradenton Cardiology Center/Manatee Memorial Hospital 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. 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. Indigo System Catheters & Separators | Penumbra Inc Suhail Dohad, MD, FACC 2: Add The complaint has been evaluated. Do not resterilize or reuse. 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 System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . 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. Unrestrained torquing or forced insertion of the catheter or SEPARATOR against resistance may result in damage to the device or vessel. Saxon RR, Benenati JF, Teigen C, et al. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. 1. Use of LIGHTNING Aspiration Tubing adjacent to other equipment should be avoided because it could result in improper operation. Penumbras IndigoAspiration System can be used to remove emboli and thrombi from vessels of the peripheral arterial and venous systems, and for treatment of pulmonary embolism. Precautions Waqas R. Qureshi, MD, MS Distal OD. Indication For Use 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 . 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. Jawairia Sahar K. Mirza, MBBS Latest System Designed for Single Session Arterial Thrombus Removal News Mechanical Thrombectomy. The patient was brought back to the cardiac cath lab for follow-up angiography that revealed TIMI 0 flow of the RCA (Figure 1). 510(k) Premarket Notification - Food And Drug Administration 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. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. Chris Metzger, MD For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. The Indigo Separator 4 is not intended for use as a guidewire. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. Gus Theodos, MD, FACC, FSCAI For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. 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 . waqas.qureshi@umassmemorial.org Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. The initial angiogram confirmed a distal occlusion of the RCA with TIMI 0 flow and extensive clot burden (Figure 1). 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. Penumbra's high-performance aspiration catheters. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. 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. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. Precautions The device is intended for single use only. Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. The INDIGO SEPARATOR is not intended for use as a guidewire. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. 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). Mechanical power aspiration with a continuous vacuum source and large lumen aspiration catheter was first introduced in the neurovascular space when Penumbra revolutionized thrombus removal for acute ischemic stroke patients. Indigo Aspiration System Intended 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. Device Name. Initial angiogram of the right pulmonary artery showing pulmonary embolism. Orange, California Cook Medical) with the Indigo System (Penumbra, Inc.) using a CAT8 catheter and SEP8 separator to maximise the debris removal. Control angiography immediately after thrombectomy demonstrated restored patency . 0, and 37. sjaymathewsmd@gmail.com Figure 2. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. 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.