cat8 penumbra catheter

Return all damaged devices and packaging to the manufacturer/distributor. The Indigo System CAT RX and Penumbra ENGINE aspiration source were crucial to the success of this case. Do not resterilize or reuse. Do not use the INDIGO Aspiration System with a pump other than the Penumbra Aspiration Pump. Disclosures: None. 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 . Applicant. The Penumbra ENGINE is intended as a vacuum source for Penumbra Aspiration Systems. Potential Adverse Events Potential Adverse Events 5 and 94. Lightning comes packaged with the Indigo CAT7, CAT8 or CAT12. Figure 2. The treatment of arterial and venous thrombus is challenging. 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. Further evaluation of the returned device revealed kinks in the catheter shaft. 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. 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. The CAT family of catheters is the foundation of Penumbra's Indigo System. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. After discussion with the family, a decision was made to take her emergently to the cardiac catheterization laboratory. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration +1(833)330-3033. 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. Precautions Do not reuse. Do not block bottom or back air vents. With a maximised inner diameter of 0.08 (2.1 mm) and a 7 French (2.3 mm) outer diameter, CAT7 is 93% the size of CAT8, now with a lower profile. Do not use kinked or damaged devices. Saxon RR, Benenati JF, Teigen C, et al. Orange, California If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Foi utilizado o dispositivo Penumbra Indigo System Separator SEP8 (Penumbra Inc.), via . Photo: Courtesy of Business Wire. Use prior to the Use By date. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Precautions The device is intended or single use only. Distal posterior tibial artery emboli occlusion. 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. Complications from the use of this device in this manner could lead to death, permanent impairment, and/or the need for emergency medical intervention. Tareq Kass-Hout. 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. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Penumbra's not relying on software alone. A woman in her 40s presented to the emergency department (ED) with acute onset chest pain of 4 hours duration. Penumbra Aspiration Pump: The CAT family of catheters is the foundation of Penumbra's Indigo system. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. Relying on a different mechanism of action, power aspiration with CAT RX and Penumbra ENGINE was able to extract the thrombus intact; thus restoring flow through the graft. 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. Ballad CVA Heart & Vascular Institute S. Jay Mathews, MD, MS, FACC The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. 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. Return all damaged devices and packaging to the manufacturer/distributor. 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. Figure 2. Disclosures: Consultant to Penumbra, Inc. A 65-year-old man presented emergently with an inferior wall MI. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. Figure 1. Peripheral Thrombectomy Indigo System Mechanical Thrombectomy CAT6 Indigo Catheter 6, Straight tip 135cm. 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). Figure 3. Latest System Designed for Single Session Arterial Thrombus Removal News Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: . This website is intended for US audience only. Do not use in an oxygen rich environment. CAT RX mechanical aspiration system powered by Penumbra ENGINE in comparison to manual syringe-based aspiration. Do not advance, retract or use any component of the Indigo Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Made of laser-cut hypotube technology, CAT7 and CAT12 are designed to increase trackability and torqueability. 510 (k) Number. Copyright 2023 Penumbra, Inc. All rights reserved. gus.theodos@bjc.org; @gtheodosmd QUICK VIEW. These benefits may suggest a reduction to cost of care, improved patient outcomes, and changes to the procedural algorithm. Mechanical Thrombectomy. This warranted the need for further innovation in the field of acute coronary syndrome.2 The goal of the Indigo System CAT RX mechanical aspiration system powered by the Penumbra ENGINE is to provide sustained aspiration for the duration of the procedure with enhanced deliverability to navigate tortuous anatomy and track to the distal coronary vasculature. Order Qty. The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove thrombus. Indication For Use gtag('config', 'UA-18982160-1'); Penumbra Inc .cls-1{fill:#a6a699;}.cls-2{fill:#b5121b;}.cls-3{isolation:isolate;fill:url(#linear-gradient);}. Giri J, Sista AK, Weinberg J, et al. 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. Potential Adverse Events 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. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. 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. 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. Cardiology; Dental; Emergency & EMT; Endoscopy; Exam & Diagnostic; . 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. 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. Possible complications include, but are not limited to, the following: INDIGO Aspiration Catheters and Separators: Throughout each case, Lightning provides procedural feedback via audiovisual cues. Penumbra introduced the Indigo System CAT RX in 2017 for the removal of fresh, soft emboli and thrombi from the . 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. 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. 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). Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. The complaint has been evaluated. 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. 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. In a retrospective analysis of patients in our practice with fresh thrombus burden, we have observed TIMI 3 restored when using CAT RX frontline.1 This is another positive patient outcome with the use of CAT RX in a case of high thrombus burden. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. Gus Theodos, MD, FACC, FSCAI Not for use in the coronaries or the neurovasculature. Figure 2. When performing aspiration, ensure that the INDIGO Aspiration Tubing is open for only the minimum time needed to remove the thrombus. J Am Coll Cardiol. Separator 8, 150 cm Length, 0.072 in. Return all damaged devices and packaging to the manufacturer/distributor. Conclusions: evaluation of the cat8 revealed that the device was fractured. 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. Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Pump. Initial angiogram showing high thrombus burden in the left circumflex artery. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. CAT7 and CAT12 are the next generation of the Indigo System Catheters. The INDIGO Aspiration Tubing: 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.

President Of Moody Bible Institute Resigns, Line Verification Is Temporarily Blocked, Articles C