News | Pulmonary Embolism | October 23, 2020

Acute Hemodynamic Improvement With Percutaneous Mechanical Thrombectomy in a Real-world Pulmonary Embolism Population

Positive results from the FLASH Registry on PE thrombectomy presented at TCT 2020

Patient case example of the FlowTriever thrombectomy device from Inari Medical Inc. in removing a pulmonary embolism and reporting blood flow and clot burden removed by the system. #TCT2020 #TCTconnect

Patient case example of the FlowTriever thrombectomy device from Inari Medical Inc. in removing a pulmonary embolism and reporting blood flow and clot burden removed by the system.
 

October 23, 2020 —  Positive results were reported on the first 230 patients enrolled in its FLASH study, a real world pulmonary embolism (PE) population, using the FlowTriever thrombectomy device from Inari Medical Inc. The FLASH Registry included high- and intermediate-risk patients, was obtained across 19 U.S. sites. 

Results were presented virtually by National Principal Investigator Catalin Toma, M.D., director of interventional cardiology at UPMC Heart and Vascular Institute in Pittsburgh, Penn., 2020 Transcatheter Cardiovascular Therapeutics (TCT) Connect virtual symposium of the Cardiovascular Research Foundation (CRF). 

FLASH is a 500-patient prospective, multicenter, single-arm registry evaluating real world patient outcomes after treatment of PE with FlowTriever. Of the first 230 patients enrolled, 98.7% (227/230) met the study’s primary endpoint of freedom from major adverse events at 48 hours. Secondary endpoints include impact on acute hemodynamics, procedural measures, 48h all-cause mortality, and longer-term patient outcomes. All secondary outcome measures analyzed showed statistically significant and clinically meaningful improvements from baseline.

“FLASH represents the largest prospective hemodynamic study of any PE treatment ever undertaken and is the first major all comers study of a purely mechanical thrombectomy approach to PE,” Toma said. “There were no deaths at 48-hour follow-up, no cardiac or pulmonary injuries, no procedure-related clinical deteriorations, and not a single instance of intracranial hemorrhage, a limitation of thrombolytic drugs. Hemodynamic parameters including pulmonary artery pressures and cardiac index improved significantly post procedure. These results were achieved in short, single session procedures. Additionally, by obviating the need for thrombolytic infusion, FlowTriever enabled patients to minimize stay in critically-needed ICU beds to a median duration of zero days following intervention.”  

Immediate post-procedure hemodynamic improvements have not been demonstrated with thrombolytic-based approaches, which can take several hours to take effect. By contrast, after clot removal with FlowTriever, patient heart rates quickly improved by an average of 23 beats per minute. The majority (77%) of patients were tachycardic (>100 bpm) pre-procedure and only 25% were tachycardic immediately afterward. Similarly, the average pulmonary artery pressure dropped a remarkable 7 mmHg, with several patients normalizing immediately after clot removal.

“FLASH reflects Inari’s long-term commitment to venous thromboembolism (VTE) patients, and to producing a robust portfolio of clinical data to further the understanding and advance the treatment of this disease,” said Thomas Tu, M.D., chief medical officer of Inari Medical. “We remain committed to revolutionizing VTE treatment by continuing to build an armamentarium of purpose-built devices that remove large clot volume from large vessels while completely eliminating thrombolytics and their consequent cost, ICU stay, and bleeding complications.”

Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases. Inari has developed two minimally-invasive, novel catheter-based mechanical thrombectomy devices that are designed to remove large clots from large vessels and eliminate the need for thrombolytic drugs. The company purpose-built its products for the specific characteristics of the venous system and the treatment of the two distinct manifestations of venous thromboembolism, or VTE: deep vein thrombosis and pulmonary embolism. The ClotTriever system is 510(k) cleared by the FDA for the treatment of deep vein thrombosis. The FlowTriever system is 510(k) cleared by the FDA for the treatment of pulmonary embolism.

Find additional TCT 2020 news, video and late-breaking studies

 

 

Related Content

Hershey's Chocolate display with samples and coco pods at the American College of Cardiology (ACC) 2012 annual meeting. The company was making the case that chocolate can be good for your heart, which is now supported by several studies. Photo by Dave Fornell

Hershey's Chocolate display with samples and coco pods at the American College of Cardiology (ACC) 2012 annual meeting. The company was making the case that chocolate can be good for your heart, which is now supported by several studies. Photo by Dave Fornell

News | Cardiovascular Clinical Studies | July 22, 2020
July 22, 2020 — Eating chocolate at least once a week is linked with a reduced risk of heart disease, according to re
The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

The first 3-D images have been created of an RNA molecule known as "Braveheart" for its role in transforming stem cells into heart cells. Credit: Image courtesy Los Alamos National Laboratory

News | Cardiovascular Clinical Studies | January 20, 2020
January 20, 2020 — Scientists at Los Alamos and international partners have created the first 3-D images of a special
Top Cardiology New in 2019 From the European Society of Cardioloigy (ESC)
News | Cardiovascular Clinical Studies | December 23, 2019
Environmental and lifestyle issues were popular this year, with pick up from both...
News | Cardiovascular Clinical Studies | November 26, 2019
November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have sele
FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp