European Journal of Cardiovascular Medicine

CAD remains one of the leading causes of morbidity and mortality worldwide, including in India, where the disease burden continues to rise due to aging, diabetes, and other metabolic risk factors. Conventional percutaneous coronary intervention (PCI) with drug-eluting stents (DES) has revolutionized revascularization; however, issues such as ISR, late thrombosis, and vessel caging continue to limit long-term outcomes. To overcome these challenges, drug-coated balloons (DCBs) have emerged as a promising “leave-nothing-behind” technology that enables local delivery of antiproliferative drugs to the vessel wall without leaving a permanent metallic scaffold (1).

The mechanism of DCBs involves short-duration inflation that allows the antiproliferative drug—supported by an excipient matrix—to diffuse uniformly into the arterial wall. This process inhibits neointimal proliferation and smooth muscle cell migration, thereby reducing restenosis (1). Initially, paclitaxel was the preferred drug because of its high lipophilicity and durable tissue retention, but concerns about delayed vascular healing and potential distal embolization encouraged the development of sirolimus-based DCBs, which use micro-reservoirs, nanoparticles, or lipid carriers to enhance drug penetration despite sirolimus’s lower lipophilicity (2,3)

Recent studies, such as the SPACIOUS trial, demonstrated that SCBs are non-inferior to PCBs in

coronary bifurcation lesions, showing significantly reduced binary restenosis (4). Similarly, India-specific PMS data from the MOZEC SEB trial reported low rates of MACE and TLR, confirming excellent safety and performance of sirolimus DCBs in real-world use (5). These findings, along with the growth of indigenous manufacturers like Meril and Concept Medical, highlight India’s increasing contribution to the global DCB market (6).

This manuscript reviews the availability, clinical evidence, and comparative performance of drug-eluting balloons in India, with a particular focus on sirolimus- and paclitaxel-coated technologies. It also discusses recent clinical trials and post-marketing outcomes that have shaped the Indian DEB market.

Overview of Drug- eluting balloon:

 DEBs are advanced angioplasty balloons specifically developed to meet these therapeutic needs and concerns by enabling localized delivery of antiproliferative agents to the vessel wall (8).

A DEB is a stent-free therapeutic device that enables uniform delivery of antiproliferative drugs directly to the vessel wall during balloon inflation. This approach aims to restore vessel patency and treat conditions such as atherosclerosis and ISR while minimizing the risk of late thrombosis, as no permanent implant remains in the artery. The underlying principle of this technology is targeted drug delivery, which promotes faster vascular healing and effectively inhibits the proliferation of smooth muscle cells (9).

Mechanism of Drug Transfer and Role of Excipients in Drug-Coated Balloons (DEBs)

DEBs are designed with an antiproliferative drug coating—most commonly paclitaxel—to prevent restenosis. These balloons deliver the drug from their coated surface to the vessel wall during angioplasty. Since the drug transfer occurs within a brief two-minute inflation period, excipients or drug carriers are incorporated to improve drug delivery efficiency and retention at the lesion site. With the help of these excipients, drug transfer is facilitated through several mechanisms, including mechanical contact, solvent-mediated diffusion, and excipient-assisted binding to the arterial tissue. Excipients play a crucial role in improving drug solubility, facilitating drug transfer, and promoting cellular uptake. Therefore, DEBs incorporate excipients—either in single or multi-layered formulations—to maintain effective therapeutic levels of paclitaxel throughout the restenosis process. Various excipients are currently utilized, including iopromide, urea, dimethyl sulfoxide (DMSO), shellac, polysorbate, sorbitol, butyryl trihexyl citrate (BTHC), and polyethylene glycol (PEG) (10).

Indications of Drug eluting balloon:

DEBs provide an alternative therapeutic approach for CAD, delivering antiproliferative drugs rapidly into the vessel wall during balloon inflation. They are an established treatment option for patients with ISR. In the case of de novo lesions in small coronary arteries, DEBs have emerged as a reliable alternative to DES, as demonstrated by several non-randomized studies and a large randomized multicenter trial showing comparable rates of MACE up to three years after treatment with either DEBs or second-generation DES (12).

The International DCB Consensus Group defines vessels with a diameter of less than 3 mm as “small.” Accordingly, small vessel disease (SVD) refers to lesions occurring in vessels with a reference diameter below 3 mm (13). SVD is relatively common, affecting up to 30% of patients with symptomatic CAD. It is particularly prevalent among individuals with diabetes or chronic kidney disease. Revascularization in SVD remains challenging due to the higher risk of adverse clinical outcomes. Because small vessels have limited capacity to accommodate neointimal growth without affecting blood flow, restenosis is more frequent after stent implantation. Therefore, minimizing late lumen loss following SVD treatment is essential for achieving favorable long-term outcomes (12).

Comparison of Sirolimus and Paclitaxel Drug-Coated Balloons:

Sirolimus and paclitaxel represent the two dominant antiproliferative drugs used on drug-coated balloons (DCBs) and drug-eluting technologies in coronary intervention, but they differ fundamentally in mechanism, tissue handling and clinical behaviour. Paclitaxel is a lipophilic mitotic inhibitor that achieves rapid arterial uptake and prolonged tissue retention after brief balloon contact, which historically made it the first successful drug for DCB delivery (1). Sirolimus (and its analogues) acts by inhibiting the mTOR pathway to block smooth-muscle cell proliferation; it is less lipophilic than paclitaxel, so contemporary sirolimus delivery platforms use microcarriers or novel excipients to achieve adequate arterial transfer and sustained release (3). Mechanistic differences translate into distinct safety and efficacy profiles in some settings: paclitaxel DCBs demonstrated early success in limiting restenosis, especially in peripheral applications, while newer-generation SCBs aim to match that efficacy with potentially improved healing biology and lower local cytotoxicity. Recent head-to-head registries and reviews suggest broadly comparable clinical outcomes for modern SCBs and PCBs across many lesion types, but longer-term and larger randomized data are still maturing (2).

From an industry perspective, the DCB market is expanding rapidly as “leave-nothing-behind” strategies gain traction. Market analyses report strong CAGR projections and growing adoption across coronary and peripheral indications, with major device companies and specialized firms competing across paclitaxel and sirolimus platforms. Adoption patterns are being shaped by device-specific performance, regulatory approvals (including recent coronary DCB approvals), and head-to-head clinical evidence; consequently, both drug types remain strategically important to manufacturers and clinicians while innovation focuses on improving drug transfer, excipients, and delivery technologies (14).

Sirolimus and paclitaxel represent the two principal antiproliferative agents deployed on drug-coated balloons (DCBs) in coronary intervention. Paclitaxel is a highly lipophilic mitotic inhibitor that enables rapid arterial uptake and prolonged retention after brief balloon contact, historically driving its early success in DCB platforms (1). On the other hand, sirolimus inhibits the mTOR signalling pathway, suppressing smooth-muscle cell proliferation and migration; its lesser lipophilicity demands innovative carrier or excipient technologies to achieve effective arterial transfer and sustained release in DCB formats (1). In hypoxic vascular environments — frequently present in advanced atherosclerotic lesions — sirolimus nanoparticle formulations more effectively inhibited endothelial and smooth-muscle cell proliferation (via HIF-1α and glycolytic pathway suppression) compared to paclitaxel nanoparticles, suggesting a potential mechanistic advantage of sirolimus in such lesion microenvironments (15). Clinically, a recent systematic review and meta-analysis of DCB-only PCIs comparing PCBs and SCBs found no significant difference in the composite endpoint of target lesion failure at 9-12 months; however, angiographically the PCB group showed a slightly larger minimal lumen diameter on follow-up, favouring paclitaxel in that metric (2). In complex bifurcated side-branch lesions treated with a main-vessel stent plus side-branch DCB, the SPACIOUS trial demonstrated that a sirolimus-coated balloon was non-inferior to a paclitaxel-coated balloon with respect to diameter stenosis at 9 months (30.5 ± 16.1% vs 33.5 ± 16.2%; p for non-inferiority < 0.01) and significantly lower binary restenosis (4.4% vs 12.8%; p = 0.043) (4).

Clinical Trial Data — DEBs in India:

In India, SCBs have moved rapidly from first-in-country trials to post-marketing real-world studies; Indian devices (for example, MOZEC SEB by Meril and MagicTouch by Concept Medical with Indian manufacturing) provide most of the India-specific evidence. Available Indian data show favourable mid- to long-term safety and efficacy for SCBs in native de-novo lesions, ISR and bifurcation settings, with low cumulative MACE and low TLR rates in post-marketing cohorts. Paclitaxel DCB experience in India is smaller in recent years (older global PCB trials informed local practice), and head-to-head Indian comparisons are limited but a recent single-centre observational ISR study reported broadly comparable clinical outcomes between PCB and SCB over long follow-up. Overall, India-specific evidence supports SCB use (favourable safety profile and acceptable efficacy), but randomized head-to-head data from India are still limited and longer-term follow-up is needed (18, 19, 5, 6).

1.          Safety — India data:

Sirolimus DCBs (MOZEC SEB, Meril): A prospective, multicentre PMS of MOZEC SEB in India (PMS/CTRI study; published 2025) enrolled ~141 patients and reported cumulative MACE 4.47% at 24 months (2 cardiac deaths, 5 MIs, 4 TLRs) with low angiographic late lumen loss (mean in-device LLL at 6 months 0.14 ± 0.37 mm in the subgroup undergoing angiography). The authors concluded favorable safety and vessel healing in a real-world Indian population (5).

Paclitaxel DCBs (India registries / single-centre): Indian single-centre and registry reports that included PCB use (and comparative cohorts) did not demonstrate an excess safety signal for paclitaxel in the Indian experience; clinical events and TLR rates were similar to international benchmarks in these series. However, there is limited large prospective RCT data from India specifically for PCBs in the last 5 years (7, 16).

Head-to-head (India observational): A prospective single-centre observational study of ISR patients treated with either PCB (n=32) or SCB (n=53) reported no significant difference in long-term cardiac death; procedural imaging (MSA) differences were observed (slightly larger post-procedural MSA with SCB group), but major safety endpoints were comparable over a median 3.8-year follow-up (7).

2.          Efficacy — India data: clinical & angiographic

SCBs (MOZEC SEB): In the Mozec SEB PMS (India), TLR was 2.99% at 24 months, and overall MACE 4.47% at 24 months with low late lumen loss (LLL) in the angiography subgroup — demonstrating acceptable efficacy across de-novo, ISR and bifurcation lesions in Indian practice (5).

PCBs: Historical global PCB trials (PEPCAD, PEPCAD-DES, BELLO etc.) showed strong angiographic efficacy; Indian registries echo angiographic benefit in ISR and small vessels, but contemporary India-only RCT data for PCBs are limited. The available Indian observational comparisons (ISR cohort above) show broadly similar mid-term clinical efficacy between PCBs and SCBs in practice (16, 7).

Bifurcation / complex lesions: Indian experience using SCBs (and reports including Indian investigators) supports SCBs as viable options in side-branch DCB strategies. The international SPACIOUS trial (which included sites and investigators collaborating globally) showed SCB non-inferiority vs PCB in side-branch bifurcation outcomes; Indian case series and bifurcation experience with MOZEC are consistent with good angiographic results (4).

Procedural / practical aspects:

Imaging & endpoints: Several Indian series used intravascular imaging (IVUS/OCT) to document minimal stent area/late lumen loss; small angiographic subgroups confirm low LLL with SCBs in Indian studies (7, 5).

Drug delivery & device differences: Indian-manufactured SCBs (MOZEC, MagicTouch production in India) use nanocarrier/solid-lipid systems for sirolimus delivery — this engineering underpins the clinical results reported in Indian PMS and regional trials (5, 17).

Clinical Evidence and Comparative Outcomes of DEBs Versus DESs:

DES use antiproliferative agents like paclitaxel, sirolimus, and everolimus to prevent restenosis by inhibiting smooth muscle proliferation. While early attempts to deliver these drugs via balloons showed potential, DES became the dominant PCI therapy. DCBs have since emerged as an effective alternative, using polyurethane or nylon balloons coated with antiproliferative drugs within a biocompatible, lipophilic polymer matrix that enhances drug transfer and retention. Typically, paclitaxel was used due to its favorable properties, though newer versions employ sirolimus or related agents with mixed results. Despite only about 15% of the drug being delivered during inflation, this is sufficient to achieve therapeutic benefit. DEBs provide uniform, high-concentration local drug delivery without a permanent implant, offering a promising approach for coronary artery disease treatment (8).

Market Trends and Innovation in India and Asia-Pacific:

The Asia-Pacific region represents one of the fastest-growing markets for drug-eluting balloons (DEBs). This rapid expansion is driven by improving healthcare infrastructure, a flourishing medical tourism sector, and increasing disposable incomes across developing nations such as China and India. With their large populations and escalating prevalence of lifestyle-related diseases, these countries provide a vast patient base and significant growth opportunities for medical device manufacturers. Furthermore, government initiatives across several Asian nations aimed at improving healthcare accessibility are fueling demand for affordable and effective treatment options like DEBs. In addition, Reflow Medical’s establishment of its European subsidiary in Landsberg am Lech, Germany, reflects a broader strategic effort to expand its reach into the Asia-Pacific (APAC) market. This move is expected to strengthen the availability of Reflow’s advanced cardiovascular solutions, including the Spur® Peripheral Retrievable Scaffold System, thereby positively impacting the APAC DEB market (11).

India’s DEB market is witnessing rapid transformation, driven by advancements in healthcare infrastructure, a rising burden of cardiovascular and peripheral vascular diseases, and an increasing focus on cost-effective, minimally invasive treatment solutions. The nation’s large and aging population, coupled with the growing prevalence of lifestyle-related disorders such as diabetes and hypertension, is fueling the demand for innovative interventional cardiology devices. DEBs are becoming increasingly popular as a stent-free therapeutic option that reduces hospital stay duration and minimizes the need for extended post-procedural care—an advantage particularly valuable in resource-limited healthcare settings. The SIRONA trial marks a significant milestone in India’s DEB landscape, highlighting the potential of SCBs as a safe and effective alternative to paclitaxel-coated devices in managing peripheral artery disease (PAD), while addressing prior safety concerns linked to paclitaxel use (11).

DEBs have emerged as a key advancement in PCI, providing an effective “leave-nothing-behind” approach for the treatment of CAD. By delivering antiproliferative drugs locally to the vessel wall during short balloon inflation, DEBs eliminate the need for permanent metallic scaffolds and thus minimize long-term risks such as late thrombosis, inflammation, and impaired vasomotion associated with stent implantation. In India, the adoption of DEBs has accelerated due to an increasing CAD burden, expansion of interventional cardiology infrastructure, and the availability of cost-effective indigenous devices. Leading Indian manufacturers such as Meril Life Sciences and Concept Medical have played pivotal roles with SCB technologies including MOZEC™ SEB and MagicTouch™, supported by strong post-marketing surveillance and registry data (5–7,11).

Globally and in India, there has been a distinct market transition from paclitaxel-based to sirolimus-based DEB technologies. As of 2024, sirolimus-coated balloons account for a growing majority of new DCB approvals and clinical trials (11). Indian manufacturers are leading this shift, driven by innovation, lower cost, and favorable safety data. Meril’s MOZEC SEB and Concept Medical’s MagicTouch have achieved strong clinical acceptance across Indian catheterization laboratories and have been included in major global studies such as the SPACIOUS and SIRONA trials (4,11). In contrast, paclitaxel-coated balloons, while still used in certain peripheral and ISR applications, are witnessing reduced adoption for coronary interventions as newer sirolimus-based devices demonstrate improved outcomes and biocompatibility (1,3,7,14).

Clinical evidence from India further supports the safety and efficacy of DEBs. The MOZEC SEB PMS study enrolled 141 patients and reported low rates of MACE 4.47% and TLR 2.99% at 24 months, with minimal angiographic late lumen loss (0.14 ± 0.37 mm), confirming excellent vessel healing in real-world settings (5). Similarly, in the SPACIOUS trial, sirolimus-coated balloons demonstrated non-inferiority to paclitaxel-coated balloons for bifurcated lesions (30.5 ± 16.1% vs 33.5 ± 16.2% diameter stenosis; p < 0.01), with significantly lower binary restenosis (4.4% vs 12.8%; p = 0.043) (4). Likewise, the Indian MOZEC SEB PMS study (141 patients) reported a 24-month MACE of 4.47% and TLR of 2.99%, supporting durable long-term outcomes (5). In a comparative Indian study of ISR patients, Ray et al. found no significant difference in long-term cardiac mortality between SCBs and PCBs over 3.8 years, though SCBs achieved a larger post-procedural minimal stent area (7).

Indian observational studies comparing PCBs and SCBs in patients with in-stent restenosis demonstrated no significant difference in long-term cardiac death or MACE, though procedural imaging parameters such as minimal stent area were slightly higher in the sirolimus group (7). In peripheral artery disease, the SIRONA trial confirmed the safety and efficacy of sirolimus-coated devices such as MagicTouch, highlighting the broad therapeutic potential of sirolimus across vascular territories (11).

Overall, available Indian data indicate that sirolimus-coated balloons match or exceed the clinical performance of paclitaxel-coated balloons in safety and efficacy outcomes, particularly for de novo lesions, ISR, and small vessel disease. The rapid growth of indigenous manufacturing, regulatory support, and favorable post-marketing data continue to strengthen India’s role in the global DEB landscape. However, most current evidence arises from registry and post-marketing studies, underscoring the need for large-scale randomized controlled trials to confirm long-term comparative outcomes in Indian populations (5,6,7,18,19).

In summary, this manuscript highlights India’s growing leadership in the global DEB market and underscores the clinical reliability of sirolimus-coated balloons as safe and effective alternatives to paclitaxel-based devices. It provides an integrated overview of technological evolution, comparative pharmacology, and real-world Indian clinical data, illustrating how locally developed sirolimus DCBs are shaping the next phase of coronary revascularization therapy.

Limitations of the India evidence

Number of large randomized head-to-head trials conducted fully in India is small. Much evidence in India is post-marketing, registry and single-centre observational data. Global randomized trials and meta-analyses remain important for definitive comparisons; however, Indian device trials (MOZEC PMS, Concept Medical registries) provide strong real-world support for SCBs (5,17).

Drug-coated balloons offer an effective, stent-free revascularization strategy with comparable efficacy to DES and advantages in reducing late complications. Paclitaxel-coated balloons provide potent, short-term antiproliferative activity, while sirolimus-coated balloons deliver controlled, biocompatible drug action that favors vessel healing. Emerging Indian evidence—particularly from the MOZEC SEB PMS and comparative ISR studies—supports sirolimus DCBs as safe, effective, and economically viable for both de-novo and restenotic lesions.

As India continues to lead in the manufacturing and clinical development of sirolimus DCBs through programs like MagicTouch and MOZEC, large multicentre randomized trials are warranted to validate long-term benefits and refine lesion-specific treatment strategies. The evolution from paclitaxel to sirolimus technology represents a pivotal shift toward safer, more durable, and patient-centric coronary intervention therapies. Continued evidence generation through large-scale, multicenter randomized studies in India will be essential to solidify their long-term clinical role.

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