Ethics & Compliance at BIOTRONIK

Revived Pulse Foundation: Offering South African Patients a Second Chance at Life

In a life-or-death situation, South African farmer Faan Botha received a donated BIOTRONIK pacemaker in 2013, profoundly transforming his life. Inspired by this experience, he founded the Revived Pulse Foundation, which, with the support of BIOTRONIK South Africa, now provides approximately 10 to 20 life-saving devices annually to patients lacking health insurance coverage. We also plan to gradually raise this level of support. 

Learn more about the Revived Pulse Foundation
Offering South African Patients a Second Chance at Life

The American Heart Association: Raising Awareness for Heart Disease and Stroke in Portland

Each year, BIOTRONIK's Portland, Oregon team wholeheartedly joins the American Heart Association's annual Heart and Stroke Walk. Their participation is a dynamic team effort, aimed at both increasing awareness and generating funds to combat heart disease and stroke, ultimately contributing to the mission of saving lives. 

Learn more about the Heart and Stroke Walk
Helping People Is at the Core of Our Business

Contact Compliance

BIOTRONIK is proud to support our employees with a strong team of legal and compliance professionals with expertise and experience leading medical device organizations focused on ethical business practices and strict adherence to all applicable laws and regulations. BIOTRONIK takes these responsibilities seriously and has implemented a comprehensive compliance program to meet these goals. For general questions, contact a member of the Compliance team directly or USCompliance@biotronik.com.

 

“In today’s business environment, it’s vital that employees are empowered to make ethical decisions in their day-to-day work that align with the organization’s values and principles. Here at BIOTRONIK, we are committed to our ethical principles and embrace the importance of trust and integrity in the workplace every day. We depend on, and expect, this commitment to ethical behavior not only from our leadership teams, but from each and every one of our employees.”

Ryan Walters, President
BIOTRONIK, Inc.

Ryan Walters, President

“Our actions and intent define us as professionals and as individuals. Doing the right thing for our patients, customer, colleagues and communities depends on ethical decision making. We should all know the laws, industry standards, and company policies that define the space in which we work. We work at BIOTRONIK to help improve and save lives every day so safeguard this critical mission by acting responsibly.”

Jason Spinazzola
VP of Compliance & Risk Management

Jason Spinazzola, VP of Compliance

Federal Transparency (Open Payments Program)

Open Payments is a US government program which collects and publishes information about financial relationships between drug and medical device companies (referred to as "reporting entities") and certain health care professionals (referred to as "covered recipients"). For additional information on the Open Payments Program, visit www.openpaymentsdata.cms.gov.


BIOTRONIK, Inc. meets the definition of a reporting entity and as such, reports payments or other transfers of value made to covered recipients each year. Data collected for Open Payments is made publicly available each year.


What health care professionals and health care institutions qualify as "Covered Entities"?
Any physician, physician assistant, nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, or certified nurse-midwife
or a teaching hospital.
 

What "transfers of value" does BIOTRONIK report?
As required, payments to covered recipients for Consulting Fees, Honoraria, Faculty/Speaker Compensation, Education, Grants, Food and Beverage, Travel and Lodging, Research, Gifts, Device Loans, Space Rental/Facility Fees, Charitable Contributions, and Debt Forgiveness will be reported each year.


How can I view Open Payments data?
To find specific data on payments made by BIOTRONIK, use the search tool located on the Open Payments website (https://openpaymentsdata.
cms.gov/search) and search by Company, entering "Biotronik" as the Company name.

For questions related to Open Payments, email sunshine@biotronik.com.

Report a Concern

BIOTRONIK provides a number of resources that employees and others can use to report a concern. Our third-party reporting hotline provider offers easy options for you to anonymously report issues via an online form or phone call. Anonymous reporting services are available 24-hours a day, seven days a week.

All BIOTRONIK personnel are expected to adhere to all applicable laws, regulations, and BIOTRONIK policies.

BIOTRONIK personnel are expected to report any potential violations immediately. Reports will be kept confidential to the greatest extent possible and BIOTRONIK does not tolerate any form of retaliation against an individual arising from a good-faith report of a potential violation. Retaliation is also prohibited against anyone who participates in an investigation of such a report.

BIOTRONIK's reporting hotline is not designed for reporting product complaints. If you are not a BIOTRONIK employee and need to report a product complaint, please call the Medical Device Reporting Department at 1-877-245-9800. BIOTRONIK employees should follow corporate complaint reporting guidelines.

Speak Up poster