Blog Tag: Commercial Launch

Medtronic’s Recent Interactions with the FDA

It has been a busy couple of months between Medtronic and the Food and Drug Administration (FDA), with Medtronic experiencing both recalls and approvals from the government agency.  Below is a brief summary of some recent of Medtronic’s recent interactions with the  FDA.

First, in early April, the FDA announced that Medtronic was notifying customers of a voluntary field corrective action for its Newport HT70 and HT70 Plus ventilators over the potential for unexpected shutdowns, which it believes are due to software issues in the devices.  MassDevice reports that is recalling well over 7,000 of the affected devices.

Next, the FDA cautioned healthcare providers against using Medtronic’s NavLock Tracker with instruments not cleared to be used with the device.  The NavLock Tracker is an accessory to Medtronic’s StealthStation navigation system for use during spinal fusions.  As a result, Medtronic is updating its labels on the devices to indicate that only Medtronic instruments should be used.

In early May, Medtronic received official FDA approval for a new drug-eluting stent (DES) known as Resolute Onyx.  According to FierceBiotech, the stent is formed from a single strand of a cobalt alloy wire with a platinum-iridium core and can provide physicians with stent sizes up to 4.5-mm and 5.0-mm.  This newly approved stent is available for use in the United States, Europe, and countries that recognize the Conformité Européene (CE) mark.

In addition, Pat Shrader, Medtronic’s Vice President of Global Regulatory Affairs, appeared on Capital Hill to request changes in device manufacturing facility inspections by government officials due to the short notice that the manufacturing facilities receive prior to inspection.  Shrader was speaking on behalf of the Advanced Medical Technology Association, which includes other companies such as 3M, St. Jude Medical, and Boston Scientific.  Ms. Shrader called for standardization of inspections by the FDA.

FDA Approves First App-Based Pacemaker Monitor

Medtronic, a medical device manufacturer based in Dublin, Ireland, recently announced FDA approval and U.S. commercial launch of its MyCareLink Smart Monitor, the first app-based remote monitoring system for implantable pacemakers.

According to Medtronic, the MyCareLink Smart Monitor includes a handheld portable device reader paired with a MyCareLink Smart mobile app on a smartphone or tablet.  The portable device reader receives pacemaker data (when placed in close proximity to the implanted device), and communicates with the mobile app on a smartphone.  The data can then be transmitted to the patient’s physician or clinic (e.g., through cellular or Wi-Fi service).  The MyCareLink Smart Monitor also allows patients to create personal profiles on the MyCareLink Connect Website and receive reminders, confirmations, and notifications about their data transmissions.  HIT Consultant reports that the MyCareLink Smart Monitor will allow for faster treatment, reduced time in clinical care facilities, and potential improvements in survival rates.

Regarding the approval, Darrell Johnson, Vice President and General Manager of the Connected Care business in the Cardiac and Vascular Group at Medtronic stated:

“As a leader in remote cardiac monitoring, Medtronic is committed to providing cardiac patients with the latest technology to improve their health and make their lives easier, while helping to reduce the costs of healthcare.  The MyCareLink Smart Monitor is just the first of many innovative solutions we are developing that leverage smart technology to increase patient engagement.”