Distal emboli causing PDA occlusion after manual aspiration. The sustained aspiration power provided by the Penumbra ENGINE allowed rapid TIMI 3 flow restoration and removal of the distal emboli. 5, 19. 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 . gus.theodos@bjc.org; @gtheodosmd gtag('js', new Date()); Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. A CAT8 Penumbra catheter was advanced over the Glidewire into the right superficial femoral artery. 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. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. The Indigo System CAT3, CAT5, CAT6, CAT8, CATD, and CAT7D are engineered to be robust, trackable, atraumatic, and well suited for the peripheral anatomy. SciELO - Brasil - Suporte mecnico extracorpreo e trombectomia por Contraindications The INDIGO Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. Penumbra CAT8 KIT Indigo Aspiration Catheter 8 & Aspiration Tubing, XTorq Tip 115cm x 8F (NON-STERILE) Expired. Use only water-based solvents for cleaning. Since launch, we have found that CAT RX has become an essential part of our treatment algorithm when thrombus is present in the coronaries. Created with Sketch. The device is intended for single use only. These types of burns heal withing 5 or 6 days without permanent scarring. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. function gtag(){dataLayer.push(arguments);} Thrombectomy & Embolization | Vascular Medical Devices - Penumbra Inc 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. CAT8 Indigo System Aspiration Catheter - TORQ - 8Fr x 85cm Penumbra System. Penumbra System BENCHMARK Delivery Catheter - MP - 6Fr x .071" x 105cm - Non-Expired: 6Fr x .071" x 105cm $550.00. Smidt Heart institute The product-specific content of this website is intended for use by healthcare professionals only. The patient was brought to the catheterization laboratory for angiography that showed stagnant flow through the saphenous vein graft (SVG; Figure 1). INDIGO Aspiration System Intended 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. 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 . 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. 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. 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. LIGHTNING Aspiration Tubing Indication for Use 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. The advantages of CAT RX with Penumbra ENGINE include the potential to remove the thrombus intact and reduce the potential of systemic embolization while also increasing the visualization of the underlying stenosis and distal vessel. Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister. The product-specific content of this website is intended for use by healthcare professionals 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. Figure 3. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Use prior to the Use By date. Penumbra Announces U.S. Commercial Availability of INDIGO System 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. Disclaimer: The opinions and clinical experiences presented herein are for informational purposes only. Maintain a constant infusion of appropriate flush solution. Brian Kolski, MD Reuse may result in canister cracking or vacuum filter blockages, which may result in the inability to aspirate. 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. PENUMBRA ENGINE Indication for Use Penumbra Aspiration Pump: Separator 8, 150 cm Length, 0.072 in. Contraindications There are no known contraindications. The product-specific content of this website is intended for use by healthcare professionals only. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F(x) The Indigo system CAT3, CAT5, CAT6, CAT8 and CATD are engineered to be robust, trackable, atraumatic and well suited for the peripheral anatomy. Precautions The device is intended or single use only. Not for use in the coronaries or the neurovasculature. The safety and effectiveness of this device for use in the treatment of ST-Elevation Myocardial Infarction (STEMI) has not been established. Final angiogram after stent placement showing resolution of underlying disease. 2023 Bryn Mawr Communications II, LLC. These pages are not intended for patients or for members of the general public. Available in a selection of sizes, the CAT family can provide access to distal peripheral vessels of the upper and lower . Preprocedure TIMI 0 flow was seen in 76.3% of patients; TIMI 3 flow immediately post-CAT RX was demonstrated in 93.2% of patients. 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. 0, 26. Indigo Aspiration System Intended Use Penumbra, Inc. One Penumbra Place. 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. Categories. PENUMBRA: CAT6 - WestCMR Potential Adverse Events 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 procedure can be performed quickly,1 which is important for symptomatic patients. The Indigo System CAT RX and Penumbra ENGINE aspiration source were crucial to the success of this case. Penumbra CAT8XTORQ115 CAT8 Indigo System Aspiration Catheter 8F Item Past Expiration. Catheters; CAT8 KIT Indigo System Aspiration Catheter 8 and Aspiration Tubing - XTORQ - 8Fr x 115cm . Do not use in the presence of a flammable anesthetic mixture with air or nitrous oxide. 3. 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. The procedure was completed with the same catheter. Indigo System | Penumbra Inc 2018;72:1589-1596. 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. The Indigo System CAT8 catheter comes in three different tip designsstraight, 45, 90which allows a wide range of rotation. The CAT family of catheters is the foundation of Penumbra's Indigo System. 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. Penumbra Indigo System | Vascular Thrombectomy This website is intended for US audience only. Mechanical thrombectomy was performed. 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. Available in a selection of sizes, the CAT family can provide access to distal peripheral . Penumbra ENGINE Indication For Use University of Massachusetts Medical School 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. 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. The Penumbra System is a fully-integrated system designed specifically for mechanical thrombectomy, first receiving 510(k) clearance by the FDA in December 2007. 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. Device Name. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. We expect the results to further refine and improve our technique for mechanical aspiration and fine-tune the use of CAT RX for patients with high thrombus burden. Learn more about Lightning. Do not use kinked or damaged devices. Since the initial launch of the Indigo System, catheter technology as well as techniques have advanced. Throughout each case, Lightning provides procedural feedback via audiovisual cues. 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. 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. Also find Catheter price list from verified suppliers with contact number | ID: 23694008673 Initial angiogram of the right pulmonary artery showing pulmonary embolism. 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.
