We are grateful to the many Biosense Webster, Inc. employees, physicians and patients who collectively have made clinical advances in the field of electrophysiology and improved the lives of heart patients everywhere.
Investigator Initiated Studies
We support unique clinical research studies of scientific and business merit with grants that provide either funding and/or products. Applications for this type of study, called an Investigator Initiated Study (IIS), receive a cross-functional scientific, business, regulatory and healthcare compliance review from a committee composed of several medical and scientific members each with a particular area of expertise.
The IIS team reviews proposed research concepts and serves to ensure that the IIS program meets all applicable ethical, scientific and strategic criteria, including conformance with applicable Johnson & Johnson Family of Companies and regulatory agency policies. The IIS program’s mission is to encourage investigators to pursue and document original cardiac arrhythmia research using Biosense Webster, Inc. technologies.
Results of these studies are usually published in peer-reviewed medical journals and/or presented at local and global medical congresses in order to share knowledge with the entire medical community.
To begin the process of submitting your IIS proposal, click on the button below to be directed to our IIS page for additional information.
Clinical Trials
Clinical Trials Around the World
We are proud to partner with leading physicians all over the world who are working to advance the treatment of complex arrhythmias, including Afib, for our patients. Some clinical studies involve human volunteers. These trials provide patients with opportunities to engage in new research treatments that are often not widely available to the public.
What is a clinical study?
A clinical study involves a form of medical research intended to further medical and scientific knowledge using human volunteers. In a clinical study, participants generally receive specific interventions according to a research protocol which may compare a new medical approach to a standard one that is already available to the public. These studies may use a new medication, treatment or medical device, such as an ablation catheter. The sponsor and physicians work together to determine the safety and potential efficacy of the intervention by measuring outcomes in the study participants.
Biosense Webster, Inc. Sponsored Clinical Trials
We recognize the importance of contributing to the knowledge base of the medical community for the management of Afib and other complex arrhythmias. We are fortunate to collaborate with physicians all over the world to introduce new possibilities and new technology to patient care. The opportunities are endless.
Clinical Trial Database
For a list of all studies utilizing Biosense Webster, Inc. technology please visit the U.S. National Institutes of Health Site.
Pre-Clinical & Outcomes Research
Research and development can happen at multiple stages in the clinical process. We believe in improving patient care and innovating arrhythmia treatments from start to finish.
Pre-Clinical Research Resources for Physicians
As a physician, you may have a research idea or innovative product concept that our Medical Science Team can facilitate. Engaging in all aspects of pre-clinical research, from evidence generation to new product development, we look forward to partnering with you to improve arrhythmia management for patients worldwide.
Outcomes Research
Clinicians, patients and policy-makers increasingly seek information about the quality, cost of care and the effectiveness of one treatment option compared to another. We invest in outcomes studies aimed at addressing these important topics and improving clinical outcomes. We utilize a number of methodological approaches to conduct our research, including economic modeling, retrospective observational studies, data mining and meta-analysis.
To request medical information related to patient reported outcomes or health economic publications, please click here.
Our Research Physicians
The relationships we have with our research and consulting physicians are central to developing new technologies and conducting our clinical studies worldwide.
Each physician is required to have a contract with us, prior to conducting any type of research-related work. Strict policies govern our relationship with the physician and institution, and we are committed to Open Payments regulations and the transparency around the financial relationships of manufacturers, physicians and teaching hospitals. Some of our policies include:
- All research payments must reflect fair market value for services provided
- All payments made to research physicians and institutions are governed by a contractual agreement
- Physicians that conduct our clinical studies or provide consulting services are selected based on their qualifications and expertise in the field of cardiology/electrophysiology
- Gifts to physicians and other healthcare personnel are not permissible (however, certain educational items may be provided, such as textbooks and anatomical models)
In the United States, Biosense Webster, Inc. operates under the AdvaMed® Code of Ethics on Interactions with Health Care Professionals (AdvaMed®), and in Europe, we operate under the Eucomed Guidelines on Interactions with Healthcare Professionals . Both are designed to facilitate ethical interactions between medical device companies and healthcare professionals to ensure that medical decisions are based on the best interests of the patient.
Innovation Alliance
Are you often thinking about ways to improve arrhythmia treatment? Do you challenge the status quo? We invite you to learn more about how the Biosense Webster, Inc. Innovation Alliance advances innovative concepts into medical practice.
Join the Biosense Webster, Inc. Innovation Alliance: Participate Today!
ABOUT BIOSENSE WEBSTER, INC. INNOVATION ALLIANCE
For more than 30 years, Biosense Webster, Inc. (BWI) has delivered groundbreaking innovations that have advanced the science and practice of electrophysiology. One of the company’s founders, Will Webster, built the company with the philosophy of listening to and fulfilling the needs of the physician.
The Biosense Webster, Inc. Innovation Alliance is designed to link physicians in the field with our corporate expertise and capabilities to collaborate and bring new products to the marketplace that will advance the treatment of heart rhythm disorders, as well as address challenges with current offerings. To this end, the Biosense Webster, Inc. Innovation Alliance will review and respond to all complete submissions in an effort to discern the most creative, valuable and executable. We invite you to learn about the Biosense Webster, Inc. Innovation Alliance and submit your product idea today.
Frequently Asked Questions and Helpful Resources
The Biosense Webster, Inc. Innovation Alliance provides a stimulating forum for exchange to move innovative ideas into proven tools and concepts for use in practice. As physicians leverage their expertise to deliver ideas, the company supports those efforts by providing the corporate expertise and capabilities to make proposed concepts a reality.
Brainstorming a Product Concept:
We want to spark your innovation! Consider the following questions to help you identify a treatment need among heart rhythm patients.
Resources
Helpful resources to search for existing electrophysiology concepts under review.
The United States Patent and Trademark Office:
http://www.uspto.gov/patents/
The U.S. Food and Drug Administration:
www.fda.gov