Innovations in Stent Design

MedTech analysts have identified that while there is a significant amount of research-led innovation in stent technology, there is also growing interest in product value engineering (PVE) and design. Frost & Sullivan has identified significant contributors the stent technology revolution.

Stent technology has significantly improved with the availability of new materials, coatings and pharmaceutical agents, as well as design breakthroughs that improve flexibility, traceability and overall architecture. The ultimate result is simplified procedures and improved patient comfort. Drug-eluting, bioabsorbable and bioresorbable stents have supplanted traditional bare-metal supports as advances in polymer technology have made the products more durable and even completely biodegradable.

Frost & Sullivan’s Advanced Medical Technologies business unit tracks stent design and delivery innovations that have disrupted the market in the past decade. MedTech analysts have identified that while there is a significant amount of research-led innovation in stent technology, there is also growing interest in product value engineering (PVE) and design—a cost-effective and efficient route for device manufacturers to bring incremental innovations to their solutions.

Frost & Sullivan has identified the following companies as significant contributors the stent technology revolution.

S.T.Stent Ltd. (Misgav, Israel)

In January 2018, S.T.Stent received approval from the U.S. Food & Drug Administration (FDA) for a first-of-its-kind stent that supports recovery after functional endoscopic sinus surgery for chronic sinusitis. The key differentiator is that the stent is made of nitinol, an alloy of nickel and titanium. Nitinol is widely used in medical devices for its shape memory: it helps the stent adapt to a patient’s sinus cavity and remain comfortably in place for as long as four weeks as the sinus tissue heals. Removal is a minimally invasive, in-office procedure. The stent has demonstrated a 100% success rate in clinical trials, and it is expected to reduce the number of revision surgeries by 30 to 50%.

About 1 million surgeries of this type are performed each year in the United States and Europe. The stent could mark a milestone in the treatment of chronic sinusitis, chronic allergic rhinitis and rhinoplasty, and as a direct stenting alternative for balloon sinuplasty.

MicroVention, Inc. (Aliso Viejo, Calif.)

The U.S. subsidiary of Japanese medical device company Terumo is a front-runner in developing cutting-edge solutions for neuroendovascular therapies, especially for brain aneurysm, ischemic stroke, carotid artery disease and neurovascular malformations. The company is pioneering a low-profile visualized intraluminal support (LVIS) feature in its LVIS and LVIS Jr stents, and received FDA premarket approval (PMA) in May 2018.  The braided, conformable, resheathable and retrievable design gives the stent the advantages of high metal coverage and end-to-end device visibility, which are critical to successful intracranial aneurysm treatment.

MicroVention has been a leader in the U.S. market for cerebrovascular diseases since 1997. In 2014, it achieved the first breakthrough for the LVIS line of stents with approval for marketing in the United States under Humanitarian Device Exemption. By now receiving PMA, a much larger patient base will get access to the stent. MicroVention also benefits from the proprietary technologies of Terumo, which will enable it to reach new heights in the field of cerebrovascular diseases. 

NuMED, Inc. (Hopkinton, N.Y.)

NuMED has more than 20 years of experience in developing innovative solutions for diagnosis and treatment of congenital heart disease and compromised peripheral arteries. It is a global leader in pediatric cardiology with a specialized product line that includes stents.

In October 2017, NuMED received FDA approval for its improved Cheatham Platinum (CP) Stent system, which conceals a tear in the right ventricular outflow tract (RVOT) conduit before implantation of a transcatheter heart valve (THV) in patients with congenital heart disease. The CP Stent has been commercially available since 2016; the new approval covers additional sizes and configurations.  

On average, in 9% of THV procedures there is a likelihood of rupturing of RVOT conduit before implantation. By using a CP Stent system to cover the tear in procedures in which a rupture occurs, surgeons can continue with the implant procedure 90% of the time and avoid an open surgery.

NuMED has a partnership with B. Braun Interventional Systems Inc. for commercial distribution of CP Stent portfolio.  With the PMA for an expanded size offering and new indication for the CP Stent portfolio, NuMED will be a company to watch in the congenital heart interventions market.

 

The Road Ahead

Concerns about the long-term effects posed by a predecessor technology are the impetus for further innovations. Bioresorbable stents have been hailed as the next big thing in stent technology, but while recognizing the potential of a completely biodegradable stent, Frost & Sullivan strongly believes in thorough evaluation of long-term outcomes and effects years after implantation. Both manufacturers and regulatory authorities must learn to look beyond short-term benefits offered by products such as Abbott’s bioresorbable vascular scaffolding (BVS). The Absorb GT1 BVS was the first fully resorbable stent to receive CE approval for commercialization in Europe in 2012, and it launched globally after receiving FDA approval in 2016. However, the product was recalled in 2017 because of an increased rate of major adverse cardiac events.  The bioresorbable stent was considered advanced compared with its predecessor (the drug eluting stent), but in light of recent developments, Frost & Sullivan recommends more rigorous clinical trial evaluation before a new technology is introduced into clinical practice.

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