Blog Tag: spinal fusion
On August 22, 2017, Emerging Implant Technologies GmbH (EIT) announced the acquisition of 22 patents and pending applications relating to 3D printed expandable spinal fusion cages based on living hinges from Dr. Morgan Lorio, a spinal surgeon based in Nashville, Tennessee. A recent published application relating to the subject matter can be found here. FIG. 3 of that application, said to illustrate a 3D model printing method, and FIG. 7 said to illustrate an intervertebral cage apparatus are reproduced below.
EIT describes itself as a German medical device manufacturer specializing in implants for spinal alignment. In July 2017, a news article noted that EIT received approval from the U.S. Food and Drug Administration (FDA) to commercialize its spinal interbody product offerings. Regarding EIT’s acquisition, Guntmar Eisen, co-founder and CEO of EIT, stated:
“This IP is our platform to take fully 3D printed fusion cages to the next level by adding functionality to our EIT cellular titanium® cages. This will give the surgeon more options intraoperatively, reduce inventory and support MIS techniques – and at the same time reduce cost of expandable cages.”
According to PRWeb, the first functional spinal fusion cages based on this patent acquisition will be launched in 2018.
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.