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Drug-eluting balloons (DEBs) are being used to treat in-stent restenosis (ISR) instead of drug-eluting stents (DES). They are covered with a polymeric matrix that contains antiproliferative medicines that are released locally at the vessel wall when the balloon inflates. DEBs shorten the period of dual antiplatelet medication, remove the danger of stent thrombosis, and allow for more focused drug delivery.
Because of their flexibility in application in complicated lesions, DEBs offer benefits over polymer-related endothelialization and stent distribution. PEO has been utilized as an excipient in a variety of pharmaceutical products for both orally and parenterally administered formulations. Due to its relatively quick dissolving profile, uncrosslinked PEO is suited for drug release throughout the DEB intervention phase.
Drug-coated balloons dilate the stenotic coronary artery while delivering medicine to decrease neointimal hyperplasia. Both the polymer and the stent platform are missing in a drug-eluting balloon, removing the necessity for any foreign item within the vascular wall that might predispose to thrombus formation and potentially easing reintervention in imprisoned side branches or restenotic veins.
Furthermore, the lack of a stent would theoretically reduce the requirement for a lengthy course of dual antiplatelet medication, making it an appealing option for patients who are prone to bleeding. Nonetheless, the most urgent constraints of this technique are the vessel’s elastic rebound and the discovery of suitable carrier molecules for antiproliferative medicines.
The majority of drug-coated balloons currently available or under investigation in Europe use paclitaxel as the antiproliferative agent of choice and have primarily been evaluated for the treatment of in-stent restenosis and peripheral arterial stenosis, particularly in anatomic locations where stents are generally avoided due to mechanical stresses, such as the superficial femoral artery.
Subjects with in-stent restenosis were randomly assigned to either normal balloon angioplasty or angioplasty with a drug-coated balloon in the Paclitaxel-Coated Balloon Catheter for In-Stent Restenosis (PACCOCATH ISR) I trial. At the year follow-up, the drug-coated balloon was linked with considerably decreased incidence of serious adverse cardiac events, a finding that was maintained.In a trial of patients with in-stent thrombosis, the drug-coated balloon outperformed restenting with a paclitaxel-eluting stent.
Despite showing promise in the treatment of in-stent restenosis, investigations employing drug-coated balloons in de novo coronary lesions have yielded inconsistent outcomes. The drug-coated balloon in conjunction with a bare-metal stent produced better angiographic outcomes than the bare-metal stent alone, but it did not outperform the DES.
Patients were randomly assigned to either a sirolimus-eluting stent or a combination of a bare-metal stent and drug-coated balloon in the Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease (PEPCAD) III trial. Not only was in-stent restenosis considerably greater in the drug-coated balloon group, but so were MI, stent thrombosis, and total lesion revascularization at months. Similarly, during PCI, the -subject Paclitaxel-Coated Balloon Versus Drug-Eluting Stent.
Despite the fact that drug-eluting stents remain the standard interventional treatment for coronary artery disease, drug-coated balloons (DCBs) provide a unique alternative therapeutic option in specific anatomic situations. The action of DCBs is based on the rapid and homogeneous transport of antiproliferative medicines into the vessel wall via a lipophilic matrix during single balloon inflation without the usage of permanent implants.
Although their use for in-stent restenosis of both bare-metal and drug-eluting stents is well known, new randomized clinical data show an excellent effectiveness and safety profile in de novo small-vessel disease with a significant bleeding risk. Other developing indications include bifurcation lesions, large-vessel disease, diabetes mellitus, and acute coronary syndromes. Because of the interplay between the various delivery balloon designs, dosages, formulations, and release methods
Although the kinetics of the medicines used are crucial, there appears to be no class effect of DCBs. The International DCB Consensus Group provides this update of previous recommendations based on the amount of recently published data, summarizing the historical background, technical considerations such as device selection and implantation technique, possible indications, and future perspectives.
Coronary heart disease (CHD) outcomes have significantly improved, which may be ascribed in part to the adoption of innovative medications (particularly statins and antiplatelet agents) and in part to the emergence of percutaneous coronary intervention (PCI). Every phase of PCI, from percutaneous transluminal coronary angioplasty to bare-metal stent and finally to drug-eluting stent, is appealing to interventional cardiologists, and considerable progress has been made for patients with CHD.
The Global Drug-Coated Balloons Market accounted for $XX Billion in 2022 and is anticipated to reach $XX Billion by 2030, registering a CAGR of XX% from 2024 to 2030.
Surmodics, Inc., a leading developer of medical device and in vitro diagnostic solutions to the health care sector, announced today that the SurVeil drug-coated balloon (DCB) has received FDA clearance.
The SurVeil DCB is currently available to clinicians in the United States for percutaneous transluminal angioplasty of de novo or restenotic lesions in the femoral and popliteal arteries with reference vessel diameters of mm, following adequate vascular preparation. In the European Union, the SurVeil DCB obtained CE Mark certification.
Obtaining FDA clearance for SurVeil DCB is one of Surmodics most significant achievements. It is a significant step forward in efforts to create next-generation solutions that will benefit millions of patients suffering from peripheral artery disease.
SurVeil DCB has exclusive worldwide marketing rights with Abbott. Surmodics will produce and supply the product, earning money from product sales to Abbott as well as a percentage of earnings from Abbott’s third-party sales. Abbott will also pay Surmodics a million dollar milestone bonus. In the third quarter of its fiscal year, the business expects to recognise roughly million in revenue linked to the milestone payment.
Surmodics continues to assist Abbott and its exclusive worldwide commercialization rights for the SurVeil DCB, building on recent accomplishments.
