Aug 7, 2019

Medtronic Statement Regarding Updated FDA Letter To Healthcare Providers On Paclitaxel Devices to Treat Peripheral Artery Disease

DUBLIN – August 7, 2019 – Medtronic plc (NYSE:MDT) today issued the following statement regarding the U.S. Food and Drug Administration's (FDA) updated Letter to Healthcare Providers for...

DUBLIN – August  7, 2019 – Medtronic plc (NYSE:MDT) today issued the  following statement regarding the U.S. Food and Drug Administration's (FDA)  updated Letter to Healthcare Providers for paclitaxel-devices in patients with peripheral  artery disease (PAD) in the superficial femoropopliteal artery (SFA):

Medtronic would like to  thank FDA and the panel members for their thoughtful deliberations and  dedication to providing physicians, patients, and administrators with updated recommendations  following the Advisory Committee meeting of the Circulatory System Devices  Panel in June. The next steps as outlined by FDA are critical to ensuring that  physicians and their patients with PAD retain the option to utilize paclitaxel-coated  therapies. The IN.PACT™ Admiral™ drug coated balloons (DCB) has demonstrated a  clear positive benefit on clinical outcomes and quality of life across multiple  randomized controlled clinical trials.

Importantly, this  guidance will allow:

  • Physicians and patients to discuss the benefits and risks of all available PAD treatment options in order to support an informed treatment decision.
  • Patients to have continued access to paclitaxel devices as a first-line treatment option, particularly those at high risk of restenosis.
  • Trial sponsors to continue enrollment in clinical studies to further evaluate the long-term safety and effectiveness of paclitaxel devices.
  • FDA and industry to analyze of additional randomized controlled trials (RCTs) and registry datasets to help provide more insights into the mortality signal in question.


Medtronic  is encouraged by this path forward, but our work to evaluate the root cause of  this safety signal is not complete. It is important to remember that causality  was not able to be established in the FDA or VIVA/NAMSA analyses. Therefore, it  is critical that Medtronic and our industry partners continue to work together  to share safety and effectiveness data to further facilitate the benefit-risk  conversation. This work is consistent with the Medtronic Mission, and we look  forward to continued collaboration with physician societies, FDA, and our  industry partners throughout the next phase of this effort.

Medtronic  remains confident in the safety and effectiveness of IN.PACT Admiral. In the  IN.PACT SFA trial, three out of four DCB patients remained intervention-free  through five years, and for DCB patients who required a repeat procedure, the  time to reintervention was prolonged for more than two years. In line with  FDA's recommendations, we encourage physicians to talk to their patients about  the benefits and risks of all available treatment options.

About Medtronic
  Medtronic plc (,  headquartered in Dublin, Ireland, is among the world's largest medical  technology, services and solutions companies – alleviating pain, restoring  health and extending life for millions of people around the world. Medtronic  employs more than 90,000 people worldwide, serving physicians, hospitals and  patients in more than 150 countries. The company is focused on collaborating  with stakeholders around the world to take health care Further, Together.

Any  forward-looking statements are subject to risks and uncertainties such as those  described in Medtronic's periodic reports on file with the Securities and  Exchange Commission. Actual results may differ materially from anticipated  results.

Julia Fuller
Public Relations

Ryan Weispfenning
Investor Relations