Blog Tag: stent
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.
Stents, which are typically inserted into a blood vessel in order to expand the vessel to prevent or alleviate a blockage, have traditionally been made from metal mesh and remained in the body permanently (or until later removed by surgical intervention). Recently, biodegradable stents (also called bioresorbable or bioabsorbable stents) have been developed. These stents serve the same purpose as traditional stents but are manufactured from materials that may dissolve or be absorbed in the body.
The Food and Drug Administration (FDA) announced in mid-2016 that it had approved the first fully absorbable stent to treat coronary artery disease. According to the FDA, the stent (ABSORB GT1 BVS, which is manufactured by Abbott Vascular and pictured below) is gradually absorbed by the body in approximately three years following implantation. Abbott reportedly received European approval for the ABSORB BVS product in 2011.
According to some commentators, biodegradable stents, like the ABSORB BVS, are the way of the future and will eventually replace conventional metallic stents. This hypothesis is consistent with research conducted by Transparency Market Research. Transparency Market Research recently published a report (Biodegradable Stents Market – Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2016 – 2024) which projects the global market for biodegradable stents to grow from $18 Million US dollars in 2015 to $1.7 Billion US dollars by 2024 (a short 9 years). This amounts to a compound annual growth rate (CAGR) of over 30%. According to the report:
[t]he biggest advantage of [biodegradable] stents is that they get entirely absorbed in the vessels over a period of time, reducing the risk of complications or infections. This advantage is the primary reason for the growth of the global biodegradable stents market.
The report goes on to state that:
[a]s compared to predecessors of biodegradable stents, the newer technology has significantly reduced the risk of thrombosis, . . . in-stent restenosis, dual anti-platelet therapy, and second surgery for removal of the stent. These factors have played a pivotal role in shaping the trajectory of the global market in a positive direction over the past few years. The efficiency of biodegradable stents has won the market numerous consumers in the recent past. Thus, several patients and cardiologists have shown a keen interest in the uptake of biodegradable stents in the treatment of coronary and peripheral artery diseases.
Other manufacturers of biodegradable stents reportedly include Elixir Medical, Biotronik, Kyoto Medical Planning, Micell Technologies, and Reva Medical. Based on this industry’s projected growth, it appears that additional companies are likely to enter the biodegradable stent market and the United States Patent Office may see a marked increase in the number of patent application filings that are directed to biodegradable stents and other biodegradable medical devices.
On August 5, 2013, TriVascular, Inc. filed a petition with the Patent Trial and Appeal Board requesting inter partes review of U.S. Patent No. 6,007,575 owned by named inventor Dr. Shaun L.W. Samuels.
The ’575 Patent is entitled “Inflatable Intraluminal Stent and Method for Affixing Same Within the Human Body.” The ’575 Patent states that it relates to “[a]n inflatable intraluminal stent for attachment to the interior surface of a tubular structure within the human body” featuring “a cuff having an inflatable chamber and a friction-enhancing outer surface” that “engages the interior surface of the tubular structure without penetration when the inflatable cuff is in an inflated condition.” Figure 1 from the ’575 Patent is shown below:
The petition seeks review of all 24 of the ’575 Patent’s claims. The petition discloses that the ’575 Patent has been asserted by Dr. Samuels against TriVascular in a lawsuit filed in the U.S. District Court for the Northern District of California. The complaint, filed on May 17, 2013, alleges that TriVascular’s “Ovation Prime™ Abdominal Stent Graft System” infringes the ’575 Patent.