Tuesday, October 3, 2023
Tuesday, October 3, 2023

Contact: 561.316.3330

INDIGO System Lightning 7 for Arterial Clot Removal Commercially Available In the U.S.

INDIGO System Lightning 7 for arterial clot removal expands Penumbra’s offering of the Indigo Aspiration System with Intelligent Aspiration for mechanical thrombectomy and is designed for single session arterial thrombus removal.

Offering a new option for physicians to address arterial thrombus removal, the Indigo System Lightning 7 combines the new Indigo System CAT™7 Aspiration Catheter with Lightning Intelligent Aspiration powered by Penumbra ENGINE®. CAT7 is a high-power, low-profile catheter that features laser-cut hypotube technology and circumferential sweep designed for dependable delivery and maximized clot extraction.

The Indigo System’s proprietary Separator™ technology is also available with Lightning 7 (Separator 7) and is designed to enable unobstructed aspiration for the duration of the procedure. Lightning Intelligent Aspiration features Penumbra’s proprietary clot detection technology that enables the operator to identify thrombus location and is also designed for blood loss reduction.

“My experience with Lightning 7 suggests that it streamlines clot removal in the peripheral arterial vasculature with low profile access, excellent trackability, and similar power to the CAT8 Penumbra catheter that was previously used for this application. The torquability makes vessel navigation much easier,” said Dr. Christopher Metzger, System Chair of Clinical Research for Ballad Health and Medical Director of Cardiac and Peripheral Cathlabs, Ballad Health, Holston Valley Medical Center, Kingsport, Tennessee. “Penumbra continues to forge ahead with yet another game-changing technology that has the potential to increase single-session thrombus removal and thereby may help improve outcomes.”

“Today in the United States, we believe the number of patients presenting to the hospital with arterial thrombus is significantly higher than patients presenting with thrombus elsewhere in the body. Conditions involving arterial thrombus are often associated with high amputation rates, and mortality as a result. We are proud to introduce another important technology to enable physicians to reduce the need for thrombolysis, which in turn can reduce demand for ICU beds,” said Adam Elsesser, president and chief executive officer, Penumbra. “We are excited by the early experience with Lightning 7 that suggests we can help physicians to simplify arterial thrombus removal with more single-session results.”

The Indigo System with Lightning is an intelligent aspiration system powered by Penumbra ENGINE and was introduced in July 2020. Lightning Aspiration Tubing has dual pressure sensors for real-time blood flow monitoring. The built-in microprocessor features a proprietary thrombus removal algorithm that automatically controls a valve in the tubing to provide continuous or intermittent aspiration. This unique mechanism of action helps optimize thrombus removal procedures by differentiating between thrombus and blood. The system is designed to aspirate continuously when in thrombus and intermittently in patent flow. When the Indigo aspiration catheter is placed at the clot and in patent flow, Lightning is designed to automatically register a change in pressure and to minimize flow with intermittent aspiration.

Throughout the case, Lightning provides procedural feedback via audiovisual cues. Lightning’s thrombus removal algorithm is designed to initiate automatic valve clicking when it senses patent flow. With automatic valve control, Lightning is designed to help reduce blood loss and allow the physician to focus on optimizing thrombus removal procedures. The Indigo System with Lightning Intelligent Aspiration is available in the United States in the following configurations: Lightning 12, Lightning 8 and Lightning 7.

The Indigo System with Lightning Intelligent Aspiration and Separators is indicated for the removal of fresh, soft emboli and thrombi from the peripheral arterial and venous systems, and for treatment of pulmonary embolism.

Medical Device News Magazinehttps://infomeddnews.com
Our publication is dedicated to bringing our readers the latest medical device news. We are proud to boast that our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall purpose and objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

Centinel Spine’s prodisc ® Continues to Change Lives After Over 30 Years and 250,000 Total Disc Replacement Implantations

The prodisc lumbar and cervical technologies will be highlighted by Centinel Spine at the upcoming 2023 annual EUROSPINE meeting and congress in Frankfurt, Germany (October 4-6, 2023). The prodisc technology portfolio now includes four cervical and two lumbar devices—5 approved by the FDA—and has been validated with a reported reoperation rate of less than 1%.

Amber Implants Announces Start of Clinical Trial with VCFix® Spinal System

This first-in-human clinical trial will assess the safety and effectiveness of the VCFix® Spinal System implant for patients suffering from vertebral compression fractures. The implant is provided with a user-friendly, single-use sterile surgical kit, ensuring perfect traceability and reducing the risk of infection. 

RaySearch Deepens Collaboration with P-Cure

The expanded collaboration will enable users of the P-Cure proton therapy system to use RayStation and RayCare in a seamlessly integrated environment. The P-Cure system is a gantry-less seated proton system, designed to fit within linac vaults, that has recently been cleared by the FDA. It is used clinically by the Hadassah Medical Center in Jerusalem – the only proton facility in the Middle East – to treat CNS, head and neck, thoracic and pancreatic malignancies.

Edinburgh-based Med-tech Firm in MBO to Expand Into New Markets and Technologies

The acquisition will enable Novarum to build on its strong lateral flow test customer base and extend into adjacent markets. 

Biomic Sciences Issues Voluntary Nationwide Recall of ION* Sinus Support, ION* Biome Sinus, and Restore Sinus Spray Products Due to Microbial Contamination

Risk Statement: In the population most at risk, patients or individuals who recently underwent nasal or sinus surgery, there is a reasonable probability that the use of the affected product could potentially result in severe or life-threatening adverse events such as bacteremia or fungemia, invasive bacterial or fungal rhinosinusitis, or disseminated fungal infection. To date, Biomic Sciences has not received any reports of adverse events related to this product.

By using this website you agree to accept Medical Device News Magazine Privacy Policy