cat8 penumbra catheter

Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 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). LIGHTNING Aspiration Tubing Indication for Use Equipment is not safe for MR use. Indigo System Intended Use 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. TIMI 3 flow was achieved in 88% of cases. 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 . 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. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. Do not resterilize or reuse. 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. 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. She had normal left ventricular systolic function with severe right ventricular dysfunction on her echocardiogram. Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. Indication For Use This is potentially more effective than diminished syringe-based aspiration. The following case reports highlight CAT RX in a multitude of unique applications as a primary frontline device to treat patients with high thrombus burden. 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. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. If the cause cannot be determined, withdraw the device or system as a unit. 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. chronic clot, atherosclerotic plaque) 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. Use prior to the Use By date. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. 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. These pages are not intended for patients or for members of the general public. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. 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. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. 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. With reperfusion to the distal vasculature and clear visualization of the underlying stenosis, a 3.5-mm stent was placed. Jawairia Sahar K. Mirza, MBBS When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Figure 1. Tareq Kass-Hout. 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. In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon The treatment of arterial and venous thrombus is challenging. 0, 23. 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. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 Indigo System CAT RX tracking through the distal posterior tibial artery. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. Unit may overheat and shut off or fail to restart if run for extended periods of time without airflow. 3. Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . Mathews SJ, Brown C, Kolski B, et al. The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. gtag('js', new Date()); The Indigo Separator 4 is not intended for use as a guidewire. Otherwise, this could result in degradation of the performance of this equipment. 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 patient had reported intermittent chest discomfort for 3 days, with some improvement with his daily medications. waqas.qureshi@umassmemorial.org The cat8 was kinked approximately 69. $399.00 EACH. Medical Director, Aortic Disease and Ischemic Limb Disease 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. 5, 21. Penumbra's high-performance aspiration catheters. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. 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 re-infuse blood or fluid from the canister back into the patient. Indication For Use Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association. 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. Available in a selection of sizes, the CAT family can provide access to distal peripheral . The Penumbra ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Do not use open or damaged packages. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. UPC: Current Stock: This item is out of stock. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). This content is not intended to offer professional medical advice. 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. Do not position the PENUMBRA ENGINE so that it is difficult to remove the power cord. Director of Cardiac & Peripheral Cath Lab The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. BJC Cardiology Penumbra, Inc. One Penumbra Place. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Do not use in oxygen rich environment. Worcester, Massachusetts Maintain a constant infusion of appropriate flush solution. 2015;372:1389-1398. The CAT family of catheters is the foundation of Penumbra's Indigo system. Separator 8, 150 cm Length, 0.072 in. Potential Adverse Events Do not resterilize or reuse. 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. 2. Copyright 2023 Penumbra, Inc. All rights reserved. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. Conclusions: evaluation of the cat8 revealed that the device was fractured. 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: . 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. Created with Sketch. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . The CAT family of catheters is the foundation of Penumbra's Indigo System. 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. If the cause cannot be determined, withdraw the device or system as a unit. Indigo Disposable Separator 8, 150 cm Length, 0.072 in. Return all damaged devices and packaging to the manufacturer/distributor. Lightning comes packaged with the Indigo CAT7 or CAT12. Order Qty. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the coronary and peripheral vasculature. 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; Angiograms showed pre- and postthrombectomy of the right pulmonary artery with modest clot debulking but significant improvement in right lung perfusion. 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 PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. Bradenton Cardiology Center/Manatee Memorial Hospital Equipment is not safe for MR use. The combination of computer-aided aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. The Indigo Aspiration System is contraindicated in: Waqas R. Qureshi, MD, MS Precautions After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. These were quickly followed by the release of the 8-F CAT8 and 6-F CAT6 in 2015. She was in a rehab facility prior to this new event recovering from her CVA. gus.theodos@bjc.org; @gtheodosmd Ruby Coil, POD, and Packing Coil are large-volume coils designed for embolization of the peripheral arterial and venous systems. Warnings/Precautions The canister is intended for single use only. Photo: Courtesy of Business Wire. Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. Circulation. Applicant. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. 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 enable access to distal peripheral vessels of the upper and lower extremities, including below the knee. The patient remained on cangrelor with no need for tirofiban. Do not use automated high-pressure contrast injection equipment with the Indigo CAT RX Aspiration Catheter because it may damage the device. 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. After one pass with CAT RX, the high thrombus burden was removed, resulting in TIMI 3 flow. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. 0, 26. The CAT family of catheters is the foundation of Penumbras Indigo System. Warnings Worcester, Massachusetts 2019;140:e774-e801. Do not use open or damaged packages. Final angiogram after stent placement showing resolution of underlying disease. Figure 1. Use the Indigo Aspiration System in conjunction with fluoroscopic visualization. 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. Penumbras IndigoAspiration System, launched in 2014, is designed to remove clot from arteries and veins in the peripheral vasculature, and for treatment of pulmonary embolism. Device Name. A minimally-invasive device, Indigo enables the restoration of blood flow in such cases as acute limb ischemia and venous thrombus. . This press release features multimedia. indicated to connect the INDIGO CAT RX Aspiration Catheters to the Penumbra Aspiration Pump. It is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions. SVG occlusions can be challenging to resolve using traditional treatment modalities. Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . Gus Theodos, MD, FACC, FSCAI Use only waterbased solvents for cleaning. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. Do not use open or damaged packages. This content is not intended to offer professional medical advice. System Chair, Clinical Research 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. 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). Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 Do not resterilize or reuse. Do not reuse. She had acute tubular necrosis with minimal urine output at the time of transfer. Indigo System CAT RX has been designed to address the limitations of traditional treatment options with manual aspiration. The INDIGO Aspiration System 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. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Penumbra's not relying on software alone. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. The Indigo SystemCAT3, CAT5, CAT6, CAT8 and CATDare engineered to be robust, durable, and trackable for use in the peripheral anatomy. Additional Details. Only use replacement fuse with correct rating (see Table 1 for fuse rating). Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. 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 kinked or damaged devices. 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. Remove and service the Penumbra ENGINE if liquids or solids have been drawn into the Penumbra ENGINE. There are no contraindications. 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. Maintain a constant infusion of appropriate flush solution. Copyright 2022 Penumbra, Inc. All rights reserved. Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump. 1. Do not advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. 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 1. 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. Do not use in oxygen rich environment. Director, Structural Heart 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. Smidt Heart institute Figure 3. 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. Precautions The device is intended for single use only. 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 . gtag('js', new Date()); The penumbra cat8 indigo system (cat8) was kinked approximately 4. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. 1. 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. Distal posterior tibial artery emboli occlusion. The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. chronic clot, atherosclerotic plaque) The cerebral vasculature Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. 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. The cerebral vasculature Potential Adverse Events Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. INDIGO Aspiration Catheters and Separators: Final angiogram showing resolution of extensive thrombus burden. 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. Otherwise, this could result in degradation of the performance of this equipment. Enter your email address and we will contact you. A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. The complaint has been evaluated. Indigo Aspiration Catheters (CAT) are the foundation of Penumbras IndigoSystem. This website is intended for US audience only. Ruby Coil, POD, and Packing Coil work in conjunction to help facilitate simplified and efficient embolization procedures. Brandenton, Florida Return all damaged devices and packaging to the manufacturer/distributor. A final angiogram revealed complete reperfusion to the dominant left circumflex artery and branches, with TIMI 3 flow (Figure 3). 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 . gtag('js', new Date()); Jolly SS, Cairns JA, Lavi S, et al. 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 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. Catheters & Separators. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. 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. Use prior to the Use By date. 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. Contraindications There are no known contraindications. Do not use automated high-pressure contrast injection equipment with the INDIGO Aspiration Catheter because it may damage the device. Figure 2. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration.

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