The Indigo System with Lightning Aspiration Tubing is a computer-aided aspiration system powered by Penumbra ENGINE. Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . Maintain a constant infusion of appropriate flush solution. Final angiogram after stent placement showing resolution of underlying disease. Final angiography was performed, showing complete resolution of the underlying lesion (Figure 2). Penumbra introduced the Ruby Coil in 2013, followed by the launch of PODin 2014 and Packing Coil in 2015. Do not use in an oxygen rich environment. 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. Most recently, Penumbra launched LP System, including Ruby Coil LP and Packing Coil LP, which are low profile microcatheter compatible (.0165 - .021 ID). 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: J Am Coll Cardiol. The system uses Penumbra's RED reperfusion catheters. Additional Details. Final angiogram after mechanical thrombectomy with CAT8 and SEP8. Penumbra Aspiration Pump: Mechanical Thrombectomy. Penumbra's high-performance aspiration catheters. Continuous Aspiration Mechanical Thrombectomy Catheters (CAT) are the foundation of Penumbra's Indigo System. 2: Add Do not resterilize or reuse. 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 patient received a 3.5- X 38-mm everolimus-eluting stent (Synergy drug-eluting stent [DES], Boston Scientific Corporation) with postdilation optimized by intravascular ultrasound (IVUS) and was then sent to the step-down unit. Angiography of the posterior tibial artery revealed embolization to the heel resulting in no flow to the foot (Figure 1). Contraindications Not for use in the coronaries or the neurovasculature. Waqas R. Qureshi, MD, MS Do not resterilize or reuse. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. Giri J, Sista AK, Weinberg J, et al. Initial angiogram showing high thrombus burden in the RCA. Chris Metzger, MD 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. After IVUS, the stent was dilated to 3.75 mm. 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. 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. 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. The Indigo System can provide immediate mechanical relief by extracting clot while decreasing pressures using sustained power aspiration without the need for thrombolytics. 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 . This content is not intended to offer professional medical advice. Otherwise, this could result in degradation of the performance of this equipment. Aspiration Tubing Intended Use Do not use in oxygen rich environment. Use the INDIGO Aspiration System in conjunction with fluoroscopic visualization. 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. Its engineers designed low-profile, high-power aspiration catheters called Cat 7 and Cat 12 that were launched in 2021. St. Joseph Hospital Thrombus aspiration in patients with high thrombus burden in the TOTAL trial. 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. We started with laser atherectomy followed by percutaneous transluminal angioplasty of the tibial peroneal trunk, peroneal artery, and posterior tibial artery. The combination of intelligent aspiration and large-lumen catheter engineering form Lightning 7 and Lightning 12: the latest generation in clot removal technology. Prior to the procedure, ticagrelor was administered and the patient was taken to the cardiac cath lab for angiography. The CAT familyof catheters is the foundation of Penumbras Indigo System. Penumbra System CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: . Otherwise, this could result in degradation of the performance of this equipment. Excessive aspiration or failure to close the INDIGO Aspiration Tubing valve when aspiration is complete is not recommended. Do not use INDIGO SEPARATOR 4 to macerate or retrieve thrombus distal to the catheter tip. 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. Penumbra's not relying on software alone. The CAT family of catheters is the foundation of Penumbra's Indigo system. It will reduce the service life of the PENUMBRA ENGINE. 2018;72:1589-1596. The patients symptoms normalized, the electrocardiogram stabilized, and the acute MI was immediately resolved. 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. 2017;377:2240-2252. 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. 2. 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. 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. 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. waqas.qureshi@umassmemorial.org Do not use petroleum based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. 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). Return all damaged devices and packaging to the manufacturer/distributor. Penumbra Aspiration Pump The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration 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. Categories. Flow through left circumflex artery post-CAT RX. This content is not intended to offer professional medical advice. Prior to use, please consult device labeling and instructions for use. Warnings/Precautions The canister is intended for single use only. 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. Initial angiogram showing high thrombus burden in the left circumflex artery. Do not advance, retract or use any component of the INDIGO Aspiration System against resistance without careful assessment of the cause using fluoroscopy. Cedars Sinai Medical Center Potential Adverse Events Penumbra System CAT8 INDIGO System Aspiration Catheter 8 - XTORQ - 8Fr x 115cm - Non-Expired: 8Fr x 115cm 0: Contact Us: RBY2C0305 Presented at: American College of Cardiologys 68th Annual Scientific Session; March 1618, 2019; New Orleans, LA. The removal of fibrous, adherent or calcified material (e.g. To avoid the risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. Please email info@medicalmaterials.com or call us at 877-663-8686 and we will try to locate the product with our suppliers. This website is intended for US audience only. If the cause cannot be determined, withdraw the device or system as a unit. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. CAT7 and CAT12 are the next generation of the Indigo System Catheters. 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. Related Items. It will reduce service life of the Penumbra ENGINE. 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. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and . gus.theodos@bjc.org; @gtheodosmd sjaymathewsmd@gmail.com 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. Contraindications Do not use open or damaged packages. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series. 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. INDIGO Aspiration System Intended Use Device Name. 0, and 37. Do not use in an oxygen rich environment. The laser-cut, reinforced hypotube catheters have a soft, atraumatic tip . Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. The patient vomited the ticagrelor within 2 hours of administration and cangrelor was started. 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 advance, retract or use any component of the INDIGO System against resistance without careful assessment of the cause using fluoroscopy. 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. 22. To avoid risk of electrical shock, this equipment must only be connected to a supply mains with protective earth. 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. The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. The PENUMBRA ENGINE is indicated as a vacuum source for Penumbra Aspiration Systems. In-Date Home; 3M KCI; Abbott; Acist; Acumed; Acutus; AD Surgical; Adhezion; Aesculap; Alcon Excessive aspiration or failure to close the INDIGO Aspiration Tubing when aspiration is complete is not recommended. The Indigo CAT RX Aspiration Catheters and Indigo Separator 4: Aspiration thrombectomy continues to have clinical benefit in modern cardiac catherization . The four cathetersCAT3, 5, 6, & 8are robust, durable, trackable, and suited for the peripheral anatomy. CAT RX has become our frontline therapy for rapid3 clot removal in the coronary arteries. Do not resterilize or reuse. Use prior to the Use By date. Brian Kolski, MD gtag('js', new Date()); function gtag(){dataLayer.push(arguments);} There was an immediate response in the clinical situation of the patient: her blood pressure stabilized into the 90s and her oxygenation improved substantially. Initial angiography revealed an occlusion of the distal RCA. This press release features multimedia. Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) based on the risk of unexpected death or serious . N Engl J Med. 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. The initial angiogram confirmed an occlusion with extensive thrombus burden of a dominant left circumflex artery and TIMI 0 flow (Figure 1). Available in a selection of sizes, the CAT family can provide access to distal peripheral . 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. 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. This website is intended for US audience only. Next Article Penumbra ENGINE Intended Use 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; Possible complications include, but are not limited to, the following: The low-profile catheter and Penumbra ENGINE are easy to set up and use. This is potentially more effective than diminished syringe-based aspiration. If the cause cannot be determined, withdraw the device or system as a unit. 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. 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. For more information on the personal data that is collected by this website, please refer to Penumbras Privacy Notice. TIMI 3 flow was achieved in 88% of cases. If such use is necessary, LIGHTNING Aspiration Tubing and the other equipment should be observed to verify that they are functioning properly. Initial experience with a mechanical aspiration catheter for thrombus removal during percutaneous intervention: a multicenter retrospective case series.