Innovative Device Launch Trends: Cardiovascular Stents Segment
New developments in coronary stent technology have so vastly eliminated adverse outcomes over the past few decades, so much so that many researchers now consider the testing of similar stent technologies to be somewhat impractical. Because adverse outcomes are so much harder to find these days, a huge number of study participants would be needed to prove one product's superiority over another. As the current market-leading coronary stents perform well and have comparable patient outcomes (within a percentage), the market has become very mature over the past few years, with products competing based on price more than on clinical data, implying that advancements in cardiac stent technology over the past few years are not significantly driving growth in the market.
Though there have been no “earth-shattering” advancements in cardiac stent technology over the past few years, stent manufacturers have recently introduced new stents that are smaller, thinner, and have more bioresorbable features. These newer developments have led to improved patient outcome rates and have sparked new hope that the entire stent can ultimately be made bioresorbable.
Stents are Now Less “Clunky”
- The introduction of the Medtronic Resolute Onyx 2.0 stent after FDA approval in February 2018 gave doctors the smallest-sized drug-eluting stent that had ever been created.
- The Resolute Onyx uses continuous sinusoid technology, which involves forming a single strand of cobalt alloy wire into a sinusoidal wave to construct a stent. To improve the radiopacity of the small stent on angiography, it has a new metal core inside the wire to make it more visible.
- In heart angioplasty, doctors pass a balloon catheter across the area of artery obstruction, and the balloon is inflated to displace plaque and widen the artery. At the same time, a stent (also called a “scaffold”) is deployed to the obstruction site and inserted into the widened artery to “prop” the artery open.
- Shortly following FDA approval, a pioneering California interventional cardiologist named Richard Schatz, MD, inserted two stents into a local man whose arteries were considered too small to use traditional stents. Dr Schatz said that blockages that used to be difficult or even impossible to clear could be treated with the updated stent technology.
- Stent technology has since been further developed; however, in its day, the Resolute Onyx 2.0 made many more patients eligible for stents.
Stent Design is Streamlined Further
- Shortly after the Resolute Onyx was approved, the US government in May 2018 approved Abbott Laboratories’ Xience Sierra cardiac stent, which was thinner, had longer "arms" and greater flexibility.
- Upon its launch in the US, Abbott touted that the product had a highly specialized coating that decreases the chance that an artery will become re-blocked over time.
- The stent was designed to successfully treat patients with more complex cardiac disease.
- More complex forms of coronary artery disease are becoming more common because heart patients are living longer. About one-third of all coronary artery disease patients present with what doctors consider technically complex cases, according to the National Institutes of Health.
- The Sierra stent was designed to ease the artery-crossing process, open arteries wider, and provide a seamless outer lining for smoother “pushability” through vessels.
- Studies of the device generated an unprecedented safety record for reducing thrombosis. Arterial thrombosis can lead to a heart attack.
- Abbott's premier product became the new “darling” of stent technology, because even more people who were previously considered ineligible for stents could be treated without heart bypass surgery.
- Further, the new stent and its impressive study outcomes made doctors more comfortable about treating patients with stents.
Keeping Up with the Joneses: Germany-Made Stent Launched in US
- Less than a year after the Abbott stent prevailed as the premier coronary stent technology, a Berlin-based company named Biotronik got its Orsiro stent approved by the FDA. The new scaffold features bioresorbable polymer and thinner struts.
- The polymer eventually dissolves, and the Orsiro’s thinner struts are associated with less damage to the vessel walls during and after stent insertions. Orsiro has the thinnest struts among all stents on the market.
- Studies show that Orsiro has even fewer adverse patient outcomes than previously approved stents, and may help reduce the need for anti-platelet therapy that is typically required following angioplasty and stent insertion.
- The Orsiro achievement, among other factors, has spread new enthusiasm for the possibilities of creating a stent that is entirely bioresorbable, as stents are not considered to have any further therapeutic benefits 9-12 months after insertion.