Cardiovascular diseases (CVDs) are a group of disorders that affect heart and blood vessels, including (but not limited to) aortic disease, coronary artery disease, deep vein thrombosis, heart failure and peripheral artery disease. As per the World Health Organization (WHO), cardiovascular diseases are estimated to be the cause of 17.9 million deaths worldwide. However, with the aid of modern medicine and technologies, identification of patients with high risk of CVDs and ensuring they receive appropriate treatment would help in preventing premature deaths. In recent years, there has been a growing focus on enhancing the efficacy of existing treatment modalities for CVDs. Specifically, stent-mediated drug delivery devices have emerged as an effective and reliable alternative to conventional routine treatment options. Given the ongoing pace of innovation in this field, adoption of cutting-edge technologies by device developers, the ever-increasing incidence of heart diseases and the rise in demand for associated treatments, we believe that the cardiovascular drug eluting stent market is likely to evolve at a rapid pace, over the coming years.
Overview of Cardiovascular Drug Delivery Devices
Controlled delivery of therapeutic cardiovascular agents has been a matter of interest for numerous researchers over the past decades. However, cardiovascular drug delivery is a challenging process owing to the complex anatomy and physiology of the vascular system. Evidently, cardiovascular diseases have been the leading cause of death around the globe and majority of such deaths have been linked to coronary artery disease. The treatment of this condition usually involves via a procedure known as percutaneous coronary intervention (PCI), which requires the use of stents and balloons.
Specifically, stents used for the treatment of coronary interventions are primarily classified into two types, namely bare metal stents (BMS) and drug eluting stents (DES). BMS is solely composed of metal and has no drug / polymer coating around it, while DES is coated with a polymer that carries an antiproliferative drug, which aims to reduce / prevent in-stent restenosis(re-narrowing of the artery previously opened using angioplasty). Another cardiovascular device is a drug-eluting balloon (DEB), which is an angioplasty balloon coated with drug. This device is usually employed to reduce the risk of developing late thrombosis caused by incomplete endothelialization.
Potential Risks Associated with Drug Eluting Stents and Balloons
Most of the challenges associated with the use of conventional balloons and stents can be mitigated through the use of DES and DEB. However, the latter device is also linked with certain complications; these have been mentioned below.
- Bleeding: In certain cases, during the insertion of a catheter, blood vessels may get damaged and cause bleeding and discomfort for the patient.
- Re-endothelialization Disruption: The drugs eluted from DES inhibit coagulation / cell proliferation which can, in some cases, slow down or entirely halt the reendothelialization process (regrowth of endothelial tissue). This further slows down the healing process of the arteries being treated using coronary angioplasty.
- Thrombosis: Thrombosis refers to the formation of blood clots in a vessel or stented area. It is considered as one of the most serious impediments associated with stent placement. It is worth noting that thrombosis is linked with various complications, such as acute coronary syndrome.
Recent Advancements in Cardiovascular Drug Delivery Devices
In the past two decades, commendable advancements have been made related to cardiovascular drug delivery devices. Nonetheless, the ideal DES is yet to be developed. The point of interest of recent technological innovations in this field is enabling decrease in the incidence of stent thrombosis and improving the safety / efficacy of drug delivery systems. Some of the recent major advancements in this domain have been highlighted below:
- Biocompatible Polymers: Majority of the drugs used in drug eluting stents are coated with a specific polymer which defines drug release and drug dose characteristics. A new generation of biocompatible polymer coatings, such as vinylidene-fluoride hexafluoropropylene copolymer and C10–C19–polyvinylpyrrolidone polymer, have shown improvement in the reduction of activated monocyte adhesion and enhance biocompatibility.
- Bioresorbable Stents (BRS): Thisisa special kind of stent that is capable of providing benefits of a DES and can completely degrade over a pre-estimated period to reduce the complications caused by conventional stents. Initially, BRS did not show promising results, as compared to conventional stents, which led to the withdrawal of such products from the market in 2017. Since then, numerous advancements have been made in this technology, in terms of utilization of different manufacturing materials and decreased strut thickness, which may lead to the re-introduction of better versions of such products in the market.
- Combination Drugs: Earlier generations of drug eluting stents used to incorporate antiproliferative drugs, such as paclitaxel and sirolimus. Over time, the -limus drug family (including several drugs, such as everolimus, novolimus, umirolimus and zotarolimus) has emerged as a better alternative for use in drug eluting stents owing to their various benefits, such as advanced kinetics and wider therapeutic index. Further, there has been a significant interest towards the use of combination of already approved drugs to address thrombosis concerns, which may lead to the development of stents coated with such formulations.
- Nanotechnology: Since the advent of the first-ever drug eluting stent made of stainless steel, various alloys, such as cobalt chromium and platinum chromium, have been used to manufacture stents. Recently, the use of nanotechnology / nanocoating has been observed in several devices that claim to reduce the incidence of in-stent restenosis.
Concluding Remarks
Over the past 40 years, interventional cardiology has observed rapid technological advancements, including the evolution of BMS to 1st, 2nd and 3rd generation DES. Following the advent of drug eluting stents, the cases of restenosis have dropped significantly. This trend is expected to continue, facilitated by the recent innovations in the cardiovascular drug delivery devices domain.
It is worth mentioning that extensive research is being carried out to develop advanced bioresorbable stents, drug combinations, polymer coatings and nanomaterials, which exhibit enhanced safety and efficacy. In this context, the efficacy and safety of a drug eluting stent depends on a number of factors, such as stent platform, manufacturing material, eluted drug, polymers used for drug delivery and pharmacological properties of the drug. Additionally, a number of novel drug and device combinations are being tested in animal models and human trials alike, in order to evaluate their ability to enable re-reendothelialization and prevent in-stent restenosis.
Further, it is interesting to note that recent advancements in the use of augmented reality (AR) and deep learning (DL) have led to the possibility of development of patient-specific stents, thereby, providing personalized treatment options for patients suffering from CVDs. Driven by a number of factors, such as the ever-increasing cases of CVDs, ongoing pace of innovation, implementation of cutting-edge technologies, and strategic initiatives undertaken by industry players to expand intellectual capital, this emerging market is expected to grow at a steady pace in the foreseen future.
About Roots Analysis
Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights. All reports provided by us are structured in a way that enables the reader to develop a thorough perspective on the given subject. Apart from writing reports on identified areas, we provide bespoke research / consulting services dedicated to serve our clients in the best possible way.
