HVAD System: Medtronic to Stop Distribution and Sale

Medtronic plc (NYSE:MDT), the global leader in medical technology, is stopping the distribution and sale of the Medtronic HVAD™ System.

HVAD System: This morning, the company notified physicians to cease new implants of the HVAD System and transition to an alternative means of durable mechanical circulatory support.

Medtronic also announced that it is developing a support program for patients who have had an HVAD implanted and for caregivers and health care professionals who participate in their care. This program is being developed with an independent panel of clinician advisors to ensure the ongoing care and safety of patients who are currently supported by the HVAD system. Though the company will stop distribution and sale of the HVAD System, Medtronic is committed to serving the needs of the approximately 4,000 HVAD patients currently implanted with the device.

Medtronic initiated this action in light of a growing body of observational clinical comparisons indicating a higher frequency of neurological adverse events, including stroke, and mortality with the HVAD System as compared to other circulatory support devices available to patients.

In addition, Medtronic previously issued an Urgent Medical Device Communication informing physicians that the HVAD pump may experience a delay to restart or a failure to restart after it is stopped. Pump restart failure can potentially worsen a patient’s heart condition, lead to a heart attack, require hospitalization, and result in death.

Considering these findings and the availability of alternative devices, Medtronic made the decision to stop the distribution and sale of the HVAD System, consistent with its commitment to prioritize patient safety.

“The Medtronic Mission guides us to always do what is in the best interests of patients and that is exactly what we are doing and will do for those impacted by this decision. There is nothing more important than the safety and well-being of patients,” said Nnamdi Njoku, president of the Mechanical Circulatory Support business, which is part of the Cardiovascular Portfolio at Medtronic. “We recognize this information may be concerning for patients and their caregivers, and Medtronic is committed to supporting them in coordination with their physicians.”

Medtronic has been working closely with the U.S. Food and Drug Administration (FDA), along with other regulatory bodies around the world, to share information related to this decision and its commitment to ongoing support for patients implanted with the HVAD device.

Patient Management Recommendations
Medtronic is committed to patient safety and to serving the needs of the approximately 4,000 HVAD patients currently implanted with the device. Medtronic has consulted with an independent panel of clinician advisors to develop patient management recommendations to reduce stroke risk and mitigate against other potential risks associated with the HVAD System. Elective explant of the HVAD device is not recommended, as risks associated with explantation may outweigh the potential benefits.

Medtronic is also developing an ongoing support program for patients who have had an HVAD implanted, caregivers, and health care professionals who participate in their care. The program will include financial assistance for eligible patients and other resources for physicians and their caregivers. Further details of the program will be announced when they become available.

Medtronic is working closely with other stakeholders including Abbott, which manufactures the HeartMate 3™ LVAD device, and with regulatory bodies globally, to help ensure that alternative treatment options are available for patients who may be candidates for a LVAD device.

Patients with a HVAD implanted should contact their physician with questions or concerns. For more information, please visit www.Medtronic.com/HVADsafety.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides our readership with breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The KnowU incorporates the sensor that the Company plans to submit to the FDA for clearance. This proprietary sensor has been tested and proven stable and accurate in the lab setting. It was included in the Company’s prototype to validate stability outside of the lab, and is now miniaturized and wearable.
The ArthroFree system is the first FDA-cleared wireless camera for arthroscopy and general endoscopy, both areas of minimally invasive surgery. The system is designed to help surgeons work with aximum dexterity and focus.
The project, which was led by the University of Southern California, included large increases in representation among men of African, Hispanic and Asian ancestries, that were contributed in part by an ongoing collaboration between the U.S. Department of Veterans Affairs and DOE reports Argonne.
This innovative software turns smartphones into medical-grade stethoscopes, allowing people to capture, analyze, and share critical heart health data with medical personnel from the comfort of any location notes Sparrow BioAcoustics.
"Taewoong Medical becoming an Olympus group company is also a major milestone in our global growth strategy," said Henry Shin, CEO of STARmed. "We look forward to our products being made available to more patients through Olympus' global distribution network."

By using this website you agree to accept Medical Device News Magazine Privacy Policy