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Indigo Aspiration System Receives FDA Clearance for Pulmonary Embolism: Removes Difficult to Access Life Threatening Clots

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, soft emboli and thrombi from vessels of the peripheral arterial and venous systems as well as for the treatment of pulmonary embolism.

New Indigo System by Penumbra

“Penumbra continues to lead the field of clot management by bringing highly innovative technology to address the challenges that we as physicians face while caring for our patients,” said Frank Arko, M.D., chief, Division of Vascular and Endovascular Surgery, Sanger Heart and Vascular Institute, North Carolina.

HTC VIVE Technology Used in Penumbra’s REAL System for Stroke Patient Recovery

REAL™ Immersive System (REAL System) is using a custom-designed VIVE Focus™ head mounted display to help patients recover from stroke and other neurological injury.

Indigo® Aspiration System IDE Trial for Acute Pulmonary Embolism Meets Primary Safety and Efficacy Endpoints

“The positive results of the EXTRACT-PE trial, the first prospective safety and efficacy study of the Indigo Aspiration System, are a step forward in building needed clinical evidence around catheter-based embolectomy in patients with acute pulmonary embolism,” said Akhilesh Sista, MD, FSIR, FAHA, EXTRACT-PE national principal investigator, chief of Vascular and Interventional Radiology at NYU-Langone School of Medicine, and vice chair of the recently published Interventional Therapies for Acute Pulmonary Embolism guidelines from the American Heart Association.

First Patient Enrolled in Study of Aspiration for Thrombus Removal in Coronary Vessels

The CHEETAH study, a prospective, multi-center U.S. study to evaluate the safety and performance of the Indigo System with CAT RX Aspiration Catheter in the coronary vessels. Introduced in 2018, 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. 

Latest Stroke Thrombectomy Aspiration Technology

The Penumbra JET 7 Reperfusion Catheter with XTRA FLEX technology is the latest advancement in the Penumbra System JET – ENGINE family of products, which was launched last September.

Penumbra Launches Latest Advancements in Stroke Thrombectomy Aspiration Technology

9/4/18;“The JET 7 Reperfusion Catheter with its advanced tracking technology and large 0.072” aspiration lumen is the most advanced device for stroke. In my clinical experience, I was able to easily and quickly navigate the JET 7 through tortuous anatomy to the face of the clot and achieve full revascularization after a single pass,” said Alejandro M. Spiotta, MD, Medical University of South Carolina, Charleston, S.C.