penumbra indigo system

Mechanical Thrombectomy Indigo System a. Methods: The "Manufacturer and User Facility Device Experience" MAUDE database was queried for . Applicant. 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. ALAMEDA, Calif.--(BUSINESS WIRE)-- Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, announced that the CHEETAH clinical study of its Indigo System CAT RX Catheter successfully met the primary endpoint and demonstrated high rates of blood clot removal, blood flow restoration and myocardial perfusion . The data were presented in a late . In 2014, Penumbra introduced the Indigo System, a continuous aspiration mechanical thrombectomy system designed to remove clot from arteries and veins in the peripheral . The Indigo Separator is advanced and retracted through the corresponding size Indigo catheter at . ALAMEDA, CA 94502. The Indigo System utilizes 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. K180105. The system is indicated for the removal of fresh, soft emboli and thrombi . 510 (k) Number. As part of the Indigo Aspiration System, the Indigo Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and . Warnings Do not use the INDIGO Aspiration System with a pump other than a Penumbra Aspiration Applicant Contact. Indigo Lightning 12 intelligent aspiration system. Penumbra, Inc. Penumbra today announced US commercial availability of the Indigo system Lightning 7. The Indigo System with Lightning is an intelligent aspiration system powered by Penumbra ENGINE. Contraindications Not for use in the coronaries or the neurovasculature. Potential adverse . The Indigo System was most recently cleared under K180939. The patient was undergoing a thrombectomy procedure in the femoral vein using an indigo system aspiration catheter 8 (cat8) and an indigo system separator 8 (sep8). During the procedure, the physician encountered resistance while advancing the sep8 through the cat8. CAT3 Aspiration Catheter Indigo System - 150cm Penumbra System. Subsequently, the sep8 became stuck at the distal end of the cat8. Penumbra's Indigo Aspiration System is currently the market leader in the US. The Indigo System is proving to be a useful tool for managing thromboembolic disease in the peripheral arteries, including visceral, upper extremity, and especially pop liteal and below the knee. Device Problem Adverse Event Without Identified Device or Use Problem (2993) The product was not returned for evaluation. The Penumbra Indigo System Separator is intended for use with our Indigo System's CAT family of catheters to enable the removal of a wide range of thrombus.. (Credit: Business Wire.) Indigo, now with Lightning, utilizes a unique mechanism of action to help optimize thrombus removal procedures by differentiating between thrombus and blood. Aspiration thrombectomy can remove thrombus without thrombolytics, but data are lacking. PEN recently announced enrollment of the first patient into its CHEETAH study. Penumbra SEP8 Indigo System, Separator 8, Size 150cm, Box of 01. 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. [2] It consists of a flexible small-bore aspiration catheter (8F & 12F) connected to a continuous aspiration system that generates a continuous aspiration power of . April 14, 2022Penumbra, Inc. announced the European CE Mark approval and commercial launch of the Indigo aspiration system with Lightning 7 and Lightning 12. 6918. January 9, 2020 ALAMEDA, Calif.-- (BUSINESS WIRE)-- Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced U.S. Food and Drug Administration 510 (k) clearance for expanded indication of the Indigo Aspiration System. The Indigo System with Lightning is an intelligent aspiration system powered by Penumbra ENGINE and was introduced in July 2020. The Indigo System CAT3, CAT5, CAT6, CAT8and CATD are engineered to be robust, durable, and trackable for use in the peripheral anatomy. The sustained aspiration power provided by the Penumbra ENGINE allowed . Indigo Aspiration Catheters (CAT) are the foundation of Penumbra's Indigo System. ALAMEDA, Calif., April 14, 2022--Penumbra, Inc.'s Indigo Aspiration System with Lightning 7 and Lightning 12 have secured CE Mark and are now commercially available in Europe. PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12 QEW. The approval for expanded indications allows Penumbra to enter the endovascular pulmonary embolism treatment market, where thrombectomy systems are the most frequently used, and is expected to grow steadily at a compound annual growth rate (CAGR) of 1% over the next ten years. Download scientific diagram | A, Penumbra Indigo System Continuous Aspiration Mechanical Thrombectomy Catheter (CAT8). The goal of mechanical thrombus aspiration is two-fold: to deliver the highest power to aspirate the thrombus and design highly deliverable, atraumatic catheters to remove thrombus from hard-to-reach vessels. Lightning's automatic valve control has been shown to reduce blood loss. Penumbra Indigo aspiration system is a suction embolectomy device that has the advantage of rapid thrombus removal without the increased bleeding risk associated with thrombolysis. Lightning 7 - Intelligent Aspiration Powered by Penumbra ENGINEhttps://www.businesswire.com/news/home/20210318005280/en/Penumbra-Announces-U.S.-Commercial-. BENCHMARK BMX 96 Access System ; Neuron MAX BENCHMARK 071 . Time represents duration of angiogram. The Indigo Aspiration System ("Indigo System") is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems using the Indigo Aspiration Catheter, Indigo Separator, Indigo Aspiration Tubing, and Penumbra Aspiration Pump. In 2014, Penumbra launched the Indigo System specifically for this application, redefining below-the-knee mechanical thrombectomy. Indigo System Lightning 12 is Penumbra's next-generation aspiration system for peripheral thrombectomy. Penumbra, Inc. Indigo System Penumbra's 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. ALAMEDA, Calif.--(BUSINESS WIRE)-- Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced U.S. Food and Drug Administration 510(k) clearance for expanded indication of the Indigo Aspiration System. PEN recently announced the commercial availability of its INDIGO System Lightning 7 in the United States. Penumbra has designed the Indigo System CAT RX device to make use of mechanical power aspiration to remove thrombus in the coronaries. Indigo Aspiration System. The device is designed for single-session arterial thrombus removal. PEN recently announced the commercial availability of its INDIGO System Lightning 7 in the United States. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. 14th April 2022. Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister. ! The Indigo System CAT RX and Penumbra ENGINE aspiration source were crucial to the success of this case. 10th January 2020. 3508. las vegas-- (business wire)-- 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 acute pulmonary Notably, Lightning 7 is designed for single session arterial thrombus removal. chronic clot, atherosclerotic plaque) The cerebral vasculature Warnings Penumbra Inc. ClinicalTrials.gov Identifier: NCT04144959 Other Study ID Numbers: CLP 15549 : First Posted: October 30, 2019 Key Record Dates: Last Update Posted: . 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. The Indigo System enables the removal of emboli and thrombi from vessels of the peripheral arterial system. Lightning enables clot detection so the physician knows when . Device Name. Objectives: This study sought to prospectively evaluate the safety and efficacy of the Indigo aspiration system in submassive acute pulmonary embolism (PE). Penumbra today announced US Food and Drug Administration (FDA) 510(k) clearance for expanded indication of the latest iteration of the Indigo aspiration system, Lightning 12. Notably, Lightning 7 is designed for single session arterial thrombus. As part of the Indigo Aspiration System, Lightning 12 is now indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems as well as for the treatment of pulmonary embolism. Successful Intelligent aspiration of Massive Pulmonary Thromboembolism with Penumbra Indigo System Lightning 12 #penumbra #indigo Liked by Bobbi Hooper Roe Fantastic job, Dr. Penumbra Indigo System Aspiration Tubing - 285cm Penumbra System. Device Classification Name. Tafti!! The company said that its Indigo CAT RX is a rapid exchange catheter intended for maximised clot removal using its large aspiration lumen, and offers advanced trackability and deliverability through seven . Penumbra introduced the Indigo System, a continuous aspiration mechanical thrombectomy system designed to remove clot from arteries and veins in the peripheral vasculature, in 2014. 8th November 2019. K142870. UPC: Current Stock: 9. Penumbra, Inc. Penumbra System Penumbra JET 7 ; Penumbra JET D ; ACE Reperfusion Catheters ; 3D Revascularization Device MAX Reperfusion Catheters ; Velocity Delivery Microcatheter ; Embolization . Healthcare company Penumbra announced that its Indigo system CAT RX catheter has achieved the primary endpoint in the Cheetah clinical study. Quantity: Decrease Quantity of Penumbra Indigo System Aspiration Tubing - 285cm Increase . Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. The Indigo Aspiration System Lightning 12 granted FDA approval. The Indigo System with Lightning is an intelligent aspiration system powered by Penumbra ENGINE. Contraindications There are no known contraindications. Background: PE treatment with thrombolytics has bleeding risks. Warnings The INDIGO Aspiration System should only be used by physicians who have received appropriate training in interventional techniques. Quantity: Decrease Quantity of CAT3 Aspiration Catheter Indigo System - 150cm Increase . 3473. While this device has proven to be safe in clinical trials, real-world data are minimal. Both technologies are part of Penumbra's Indigo system that is designed for single session arterial and venous thrombus removal, including the treatment of pulmonary embolisms. With previous generations of Indigo, the average operator recognized patent flow and turned off aspiration manually within a few seconds. Penumbra, a global healthcare company, has secured the expanded US Food and Drug Administration 510 (k) approval for the new generation of its Indigo Aspiration System, Lightning 12. About 400 patients are expected to be enrolled at 25 centers in CHEETAH. In the study, Penumbra's . The Penumbra Indigo System Separator is intended for use with our Indigo System's Continuous Aspiration Mechanical Thrombectomy catheter to aid in the removal of clot from the body. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. The trial has shown the safety and performance of continuous aspiration thrombectomy with Indigo system CAT RX catheter in high-risk patients with acute coronary syndrome. The primary objective of this retrospective case review study is to determine the safety and effectiveness of the Penumbra and Indigo Systems for mechanical thrombectomy in a cohort of patients with confirmed peripheral or visceral arterial occlusion or embolus. About the Indigo System. peripheral mechanical thrombectomy with aspiration. Indigo System Penumbra ENGINE CATRX As part of the Indigo Aspiration System, the Indigo CAT RX Aspiration Catheters and Indigo Separator4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. The CAT8 is indicated for removal of emboli and thrombi from the peripheral . 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. PEN. Penumbra Inc. ClinicalTrials.gov Identifier: NCT05003843 Other Study ID Numbers: 19458 : First Posted: August 12, 2021 Key Record Dates: Last Update Posted: . $250.00) Model #: CAT3 OEM: Penumbra System Expiration Date: 2021-2022 Size: 150cm . This article describes the Indigo System (Penumbra, Inc.), a new technology that became commercially available in the United States in 2014. This is a retrospective, single arm, multi-center trial. Risk Information A Study of Patients With Lower Extremity Acute Limb Ischemia to Remove Thrombus With the Indigo Aspiration System (STRIDE) . Dr. Teigen: The Penumbra ENGINE Pump is connected to the Lightning device and provides a sustained suction at 29 in Hg. Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] Applicant. Penumbra has announced US Food and Drug Administration (FDA) 510 (k) clearance for expanded indication of the Indigo Aspiration System. The Indigo System, clinical study (EXTRACT-PE) was cleared in K192833 (reference device). This unique mechanism of action helps optimize thrombus removal procedures by differentiating between thrombus and blood. Device Name. Methods: This study was a prospective, single-arm, multicenter study that enrolled . 1899. Indigo system Lightning 7. The Indigo Aspiration System is comprised of several devices: Indigo CAT Mechanical Thrombectomy Catheter Indigo Separator UPC: Current Stock: 4. The Indigo System Lightning 12 (Penumbra) is now commercially available in the USA, the company has revealed. November 5, 2021Penumbra, Inc. announced that the CHEETAH clinical study of its Indigo system CAT RX continuous aspiration thrombectomy catheter successfully met the study's primary endpoint and demonstrated high rates of blood clot removal, blood flow restoration, and myocardial perfusion in conjunction with percutaneous coronary intervention (PCI) in patients with high thrombus burden. (A) An enlarged image of the Indigo aspiration catheter; (B) the Indigo aspiration pump producing sustained aspiration power at -28.5mm/Hg. As part of the system, Indigo Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the . The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. Both technologies are part of Penumbra's Indigo aspiration systemnow with Intelligent Aspiration for mechanical thrombectomy and are designed for single . PENUMBRA, INC. 1351 HARBOR BAY PKWY. From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event. Penumbra has announced that its Indigo aspiration system with Lightning 7 and Lightning 12 have secured CE mark and are now commercially available in Europe. SYK. 22. The first patient has been enrolled in Penumbra's CHEETAH post-market study to evaluate the Indigo System with CAT RX Aspiration Catheter in the coronary vessels. Contraindications The Indigo Aspiration System is contraindicated in: The removal of fibrous, adherent or calcified material (e.g. It consists of a flexible small-bore aspiration catheter (8F & 12F) connected to a continuous aspiration system that generates a continuous aspiration power of 28 . The Indigo System Lightning 12 is Penumbra's newest generation aspiration system for peripheral thrombectomy. Indigo Aspiration system (Penumbra) Penumbra 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 acute pulmonary embolism (PE). The Indigo System (Penumbra, Inc.) has been designed to address the limitations of the traditional treatment options. March 18, 2021Penumbra, Inc. announced the commercial availability of the Indigo system Lightning 7 in the United States. Penumbra Indigo aspiration system is a suction embolectomy device that has the advantage of rapid thrombus removal without the increased bleeding risk associated with thrombolysis. PC400 Penumbra SMART COIL POD400 & PAC400 Access . GuruFocus Article or News written by Business Wire and the topic is about: With the addition of larger 6- and 8-F systems and a venous indication, the Penumbra Indigo System is designed to address many of these limitations by bringing more powerful, larger-bore aspiration catheters with greater trackability to the peripheral vasculature to evacuate greater thrombus burdens from large vessels. The multi-center U.S. study aims to assess safety and performance of the Indigo System with . 18th March 2021. Lightning 12 combines the new Indigo System CAT12 Aspiration Catheter with Lightning Intelligent Aspiration, enabling physicians to focus on optimizing thrombus removal using the system's unique clot detection mechanism. Frontline treatment with Indigo Aspiration System in the target venous segment per Investigator decision; Patient is 18 years of age; . Penumbra, Inc. USA One Penumbra Place Alameda, CA 94502 USA 1.888.272.4606 T 1.510.748.3200 F 1.510.748.3232 order@penumbrainc.com info@penumbrainc.com Penumbra Europe GmbH Am Borsigturm 44 13507 Berlin Germany T +49 30 2005 676-0 F +49 30 2005 676-10 de-order@penumbrainc.com info@penumbrainc.de Penumbra Neuro Australia Pty Ltd $100.00) Model #: IST3 OEM: Penumbra System Expiration Date: 2021-2022 Size: 285cm . As part of the Indigo Aspiration System, Lightning 12 (Indigo System CAT . Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. Lightning 12 and Separator 12 Now Indicated for Treatment of PE Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced U.S. Food and Drug Administration 510(k) clearance for expanded indication of the latest iteration of the Indigo Aspiration System, Lightning 12. the latest generation of penumbra's continuous aspiration thrombectomy system features indigo system lightning 12 which combines the new indigo system cat 12 aspiration catheter with lightning. Penumbra, Inc. . Data from the EXRACT-PE trial, published online first in the Journal of the American College of Cardiology (): Cardiovascular Interventions, found that the Indigo Aspiration system (Penumbra) met its predefined safety and efficacy endpoints for the . 510 (k) Number. Lightning 7 expands Penumbra's offering of the Indigo aspiration system with intelligent aspiration for mechanical thrombectomy. K192833 Indigo Aspiration System Penumbra, Inc. K180466 FlowTriever Retrieval/Aspiration System Inari Medical, Inc. K202821 Page 2 of 4 1.7 Predicate Comparison System . Penumbra (NYSE:PEN) said its Indigo Aspiration System with Lightning 7 and Lightning 12 secured CE Mark (Conformit Europenne) and are now commercially available in Europe.The company said both . Background: The Penumbra Indigo aspiration system (Penumbra Inc., Alameda, CA, USA) is a suction embolectomy device that was cleared by the Food and Drug Administration for use in acute pulmonary embolism (PE). CAT12 is a . According to the . Alameda, CA-based Penumbra's Indigo System uses mechanical power aspiration to remove thrombus in the . In addition, Penumbra has announced the appointment of interventional radiologist Corey L Teigen (formerly Sanford Health, Fargo, USA) as chief scientific officer, and interventional radiologist James Benenati (formerly Miami Cardiac . The EXTRACT-PE trial demonstrated that the Indigo Aspiration System showed alameda, calif.-- (business wire)-- 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 appointments of corey l. teigen, m.d., to chief scientific officer and james f. The Penumbra Indigo System Separator is intended for use with our Indigo System's CAT family of catheters to enable the removal of a wide range of thrombus. As part of the Indigo aspiration system, Lightning 12 (Indigo system CAT 12 aspiration catheter with lightning intelligent aspiration) and Separator 12 are now indicated for the removal of fresh, [] Penumbra ENGINE facilitates an easy, simple set-up and the integrated clot catcher allows for immediate live feedback of thrombus removal during cases. Penumbra, Inc. (PEN Quick Quote PEN - Free Report) recently announced the commercial availability of its INDIGO System Lightning 7 in the United States.Notably, Lightning 7 is designed for single . The Indigo System Lightning 12 (Penumbra, Inc.) is an intelligent aspiration system powered by the Penumbra ENGINE .

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