NORTH AMERICAN BUSINESS
  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS
No Result
View All Result
NORTH AMERICAN BUSINESS
  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS
No Result
View All Result
NORTH AMERICAN BUSINESS
No Result
View All Result
Home ALL Healthcare

Boston Scientific Initiates Randomized Controlled Trial for the EkoSonic™ Endovascular System

by Ed Johnson
August 5, 2021
A A
The EkoSonic™ Endovascular System

The EkoSonic™ Endovascular System

Study is first to compare interventional therapy in combination with anticoagulation to anticoagulation alone for treatment of pulmonary embolism

MARLBOROUGH, Mass., Aug. 4, 2021 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) has commenced enrollment in the HI-PEITHO clinical trial, a collaborative research study with the Pulmonary Embolism Response Team (PERT) Consortium and the University Medical Center of the Johannes Gutenberg University of Mainz comparing use of the EkoSonic™ Endovascular System (EKOS) in combination with anticoagulation to anticoagulation alone for the treatment of acute, intermediate-high-risk pulmonary embolism (PE).

Each year nearly one million patients in the U.S. and Europe are affected by PE, a blood clot causing a blockage in one or more pulmonary arteries within the lungs, representing the leading cause of in-hospital death in the United States.i,ii In intermediate-risk or high-risk cases of PE, the blockage may lead to a strain on the heart’s ability to pump blood through the lungs and can be fatal. The current standard of care for PE is anticoagulation, though there are disparate guidelines to direct safe and effective treatment of patients with intermediate-high-risk PE.

“This first-of-its-kind international randomized controlled trial is intended to address current gaps in clinical guidelines and underscores our support of the highest level of research that may enable physicians to make data-based clinical decisions when choosing the best therapy for their patients with PE,” said Michael R. Jaff, D.O., chief medical officer and vice president clinical affairs, technology and innovation, Peripheral Interventions, Boston Scientific.

The EKOS system uses ultrasound energy in combination with a thrombolytic drug to dissolve blood clots and restore blood flow in patients with PE and peripheral arterial occlusions. The ultrasound technology used by the EKOS system accelerates thrombolysis – the breakdown of the clot – minimizing the time it takes to treat a patient and lowering the necessary thrombolytic dose, which can result in optimized outcomes and a lower risk of bleeding.

“I am honored to be part of this study’s global leadership whose mission is to bring forth guidelines-informing data that will ensure physicians can feel confident in the most appropriate strategy for treating patients with intermediate-high-risk PE,” said Stavros Konstantinides M.D., Ph.D., FESC, FRCP (Glasg.), study co-lead principal investigator, professor and medical director, Center for Thrombosis and Hemostasis, University Medical Center of the Johannes Gutenberg University of Mainz, Germany.

The randomized HI-PEITHO trial will enroll up to 544 patients with confirmed acute, intermediate-high-risk PE at as many as 65 sites in the U.S. and Europe. The trial, which will follow patients for one year, will assess whether treatment with the EKOS system in combination with anticoagulation is associated with a significant reduction in adverse events compared to anticoagulation alone, within seven days of randomization. The composite primary endpoint is defined as PE-related mortality, cardiorespiratory decompensation or collapse and non-fatal symptomatic and objectively confirmed recurrence of PE.

“Optimal treatment of PE is still poorly understood and there is a need for a coordinated institutional approach to this complex, life-threatening problem,” said Kenneth Rosenfield, M.D., study co-lead principal investigator and section head, Vascular Medicine and Intervention, Division of Cardiology, Massachusetts General Hospital, Boston. “The lead investigators of the trial are pleased to collaborate with the PERT Consortium, which is committed to evidence-driven therapy and is proud to take part in the HI-PEITHO study, aiming to advance the care of patients with PE.”

Tags: < New Launches
ShareTweetShareSend

Related Industries

Healthcare

Boston Scientific Announces Agreement to Acquire Relievant Medsystems, Inc.

September 20, 2023
Healthcare

BD Ranks in Top 10 for Transparency, Awarded Best Code of Conduct in 2023 U.S. Transparency Awards

September 20, 2023
Healthcare

Celanese Announces Agreement with the Population Council for Sustained Release Dual-API Therapeutic

September 13, 2023
Healthcare

Thermo Fisher Scientific and National Minority Quality Forum Collaborate to Make Clinical Research More Accessible to Historically Underserved Communities

September 8, 2023
Healthcare

Abbott to Acquire Bigfoot Biomedical, Furthering Efforts to Develop Personalized, Connected Solutions for People with Diabetes

September 6, 2023
Healthcare

AMGEN AND HORIZON THERAPEUTICS PLC RESOLVE FTC LAWSUIT, CLEARING PATH TO CLOSE ACQUISITION

September 2, 2023

Brillio Announces Investment by The Orogen Group

September 6, 2023

...

Otis Marks 170 Years Since First Elevator Sale

September 21, 2023

...

Schneider Electric Unveils Latest Texas Manufacturing Plant as Part of a $300 Million Investment in U.S. Manufacturing

September 15, 2023

...

Louise Pentland Named Chief Counsel For Disney Parks, Experiences And Products

September 7, 2023

...

chevron acquires majority stake in the advanced clean energy storage hydrogen project in delta, utah

September 13, 2023

...

Microsoft and Oracle expand partnership to deliver Oracle Database Services on Oracle Cloud Infrastructure in Microsoft Azure

September 15, 2023

...

Accelera by Cummins, Daimler Truck and PACCAR form a joint venture to advance battery cell production in the United States

September 8, 2023

...

Carrier Named a TIME World’s Best Company

September 13, 2023

...

Blackstone Integrates Leading Credit and Insurance Businesses to Form Blackstone Credit and Insurance (BXCI) in Push Toward Next $1 Trillion

September 14, 2023

...

NORTH AMERICAN BUSINESS (www.na-biz.com) is a leading source of business and corporate news, information, industry trends, market updates and insights across a broad spectrum of industries in North America and worldwide.

MENU

  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS

CONTACT US

EDITORIAL:     editor#na-biz.com

PARTNERSHIP:     biz#na-biz.com

HUMAN RESOURCE:     hr#na-biz.com

* (replace # with @)

  • Official Site

Copyright © NORTH AMERICAN BUSINESS All rights reserved.

No Result
View All Result
  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS

Copyright © NORTH AMERICAN BUSINESS All rights reserved.