Paclitaxel coated balloon. Medical search. Frequent questions

In the U.S., the Agent™ Paclitaxel-Coated balloon catheter is investigational and not available for sale. (bostonscientific.com)
The global drug-coated balloon catheter market size was valued at USD 642.0 million in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 8.0% from 2023 to 2030. (grandviewresearch.com)
For instance, Terumo Corporation stated in April 2022 that the trial using its most recent bobby balloon guide catheter has enrolled its first patient. (grandviewresearch.com)
Watch this video to discover something about SeQuent Please NEO: Clinically proven Polymer-free Drug Coated Balloon Catheter - NSE Alpha: Scoring Balloon Catheter for effective lesion preparation. (bernardocortese.com)
The FDA has granted B. Braun Interventional Systems breakthrough device designation for the company's SeQuent Please ReX drug-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter for the treatment of coronary in-stent restenosis (ISR). (drugdeliverybusiness.com)
With superior cross and track, powerful dilatation, longer lengths, and smaller sheath sizes, the Mustang Balloon Catheter is the 0.035' workhorse balloon that offers excellence across the board. (vitaminschannel.com)
The Sterling™ Balloon Catheter family † offers best-in-class lesion entry profile and deflation times* with the most clinically comprehensive size offering and indications available. (vitaminschannel.com)
Treatment of small coronary arteries with a paclitaxel-coated balloon catheter. (ihr-herz.de)
Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. (ihr-herz.de)
The US FDA has approved the first drug-coated balloon (DCB) for the treatment of peripheral arterial vascular disease, the Lutonix 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (Lutonix DCB). (medscape.com)

For patients in whom medical and exercise therapy fail or those who have claudication symptoms that are lifestyle-limiting, surgical treatment includes either open bypass surgery or endovascular therapy (eg, stents, balloons, or atherectomy devices). (medscape.com)
One week after the publication of a meta-analysis suggesting a signal of late deaths in patients treated with paclitaxel-coated balloons and stents for peripheral artery disease, two trials have been halted and leaders of the VIVA meeting have announced they will convene a special forum in the coming months to discuss the issue further. (tctmd.com)
As TCTMD reported , the meta-analysis by Konstantinos Katsanos, MD, PhD (Patras University Hospital, Rion, Greece), and colleagues, published in the Journal of the American Heart Association , examined data from 28 trials in which paclitaxel-coated balloons or stents were compared with uncoated balloon therapy for the treatment of lesions in the femoral and/or popliteal arteries. (tctmd.com)
A recent meta-analysis by Konstantinos Katsanos (Patras, Greece) et al , published in the Journal of the American Heart Association , had contradictory conclusions, reporting an increased risk of death at two and five years following the use of paclitaxel-coated balloons and stents in the femoropopliteal artery. (vascularnews.com)
Furthermore, our cohort is homogenous, consisting only of patients treated with drug-coated balloons and a paclitaxel dose of 3mg/mm 2 , while Katsanos included drug-coated balloons with different paclitaxel dosages and paclitaxel-eluting stents with very different drug release properties. (vascularnews.com)
Safer access: More trans-radial approach Better stents and better stenting technique Better PCI technique: Better kissing, NC balloon. (bifurc.eu)
The results of a systematic review and meta-analysis of randomized controlled trials conducted by Konstantinos Katsanos and his colleagues have showcased an increased risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the lower limbs. (cardiologynownews.org)

Paclitaxel has been used to prevent restenosis in blood vessels. (elsevierpure.com)
Drug-coated Balloons for the treatment of coronary in-stent restenosis: a randomised, multicentre, controlled clinical study: Christian W. Hamm, Ph.D., will present at 14:45 in room 342B. (bostonscientific.com)
The drug-coated balloon catheters are also known as drug-eluted balloon catheters which are designed to dilate the stenotic coronary artery and used in the treatment of in-stent restenosis (ISR). (grandviewresearch.com)
Drug-coated/drug-eluting balloons are used by patients to treat coronary atherosclerosis and prevent restenosis. (grandviewresearch.com)
Peripheral vascular balloon catheters enhance the safety of patients throughout surgical treatments by assisting with drug delivery, restricting the growth of vascular smooth muscle cells amid neointimal growth & development, and inhibiting restenosis. (grandviewresearch.com)
Drug-coated balloons (DCB), also referred to as drug-eluting balloons (DEB), were created as a way to reduce very high restenosis rates in peripheral vessels. (researchandmarkets.com)
The new balloons broadened physicians' treatment options for peripheral artery disease (PAD) patients with a high risk of restenosis and expand the Stellarex portfolio. (researchandmarkets.com)
He says: "Paclitaxel-coated technologies have been proven to be highly effective in reducing the rate of restenosis in the superficial femoral artery and the popliteal artery, so far with virtually no side effects. (vascularnews.com)
The In.Pact Admiral drug-coated balloon was the first DCB to receive approval by the FDA for the treatment of in-stent restenosis and lesions up to 360mm in length. (dicardiology.com)
Safety and efficacy of paclitaxel drug-coated balloon in femoropopliteal in-stent restenosis. (yalemedicine.org)
Anantha-Narayanan M, Love K, Nagpal S, Sheikh AB, Regan CJ , Mena-Hurtado C. Safety and efficacy of paclitaxel drug-coated balloon in femoropopliteal in-stent restenosis. (yalemedicine.org)

The COVID-19 pandemic had a major impact on the drug-eluting balloon catheters sector, due to the postponement of peripheral, interventional, along with cardiovascular surgical procedures. (grandviewresearch.com)
For instance, Cardiovascular Systems introduced advanced peripheral balloon catheters for complicated lesions in April 2021. (grandviewresearch.com)
As an alternate drug-eluting device to the currently available paclitaxel coat balloon platforms for the management of peripheral artery disease (PAD), sirolimus-coated balloons (SCB) have shown tremendous potential. (grandviewresearch.com)
Also shared at Charing Cross were subanalyses of the IN.PACT Global Study supporting the use of Medtronic's IN.PACT Admiral drug-coated balloon for peripheral artery disease (PAD) in patients with complex and calcified lesions. (medpagetoday.com)
2016 ) [Drug coated balloon with paclitaxel for the treatment of symptomatic peripheral artery disease: early and midterm results]. (academictree.org)
Becton Dickinson (NYSE:BDX) is planning to close a Minnesota plant that makes its Lutonix drug-coated balloon next year, as the company looks to consolidate its peripheral intervention business. (drugdeliverybusiness.com)
The FDA said last week that its preliminary review of long-term follow-up data found a "potentially concerning signal" of increased long-term mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices compared to those treated with bare devices. (drugdeliverybusiness.com)
Cardiovascular Systems (CSI) has partnered with Chansu Vascular Technologies (CVT) to develop novel peripheral and coronary everolimus drug-coated balloons (DCBs). (cardiovascularnews.com)
Peripheral Cutting Balloon (PCB) is designed to minimize vessel trauma with its unique mechanism of action. (vitaminschannel.com)
VentureMed Group has announced new data presentations on the treatment of peripheral arterial disease (PAD) with drug-coated balloon (DCBs) in addition to 12-month AV Registry Data. (renalinterventions.net)
In peripheral artery disease, DCB therapy has proven superior to balloon angioplasty for treatment of de novo femoropopliteal and below-the-knee disease. (l2mtech.de)
June 15, 2018 - Medtronic plc has received U.S. Food and Drug Administration (FDA) approval for 200mm and 250mm lengths of the In.Pact Admiral Drug-Coated Balloon (DCB) to treat long superficial femoral artery (SFA) lesions in patients with peripheral artery disease (PAD) . (dicardiology.com)
The results of a real-world safety analysis showed that over a follow-up period of up to 11 years, there was no evidence of increased mortality in patients who underwent endovascular revascularization of peripheral vessels with paclitaxel-based drug-eluting devices (DED). (cardiologynownews.org)

The paclitaxel-coated balloon (PCB) is a useful device for percutaneous coronary intervention (PCI). (asiaintervention.org)
Medtronic (NYSE:MDT) said last week that its clinical study comparing the In.Pact AV drug-coated balloon to percutaneous transluminal angioplasty (PTA) met primary safety and effectiveness endpoints. (drugdeliverybusiness.com)
Drug-coated balloon percutaneous transluminal angioplasty should therefore be preferred to plain balloon angioplasty in all patients with steno-occlusive femoropopliteal lesions of the superficial femoral artery and popliteal artery, irrespective of lesion types and patient risk factors or comorbidities. (vascularnews.com)
The DCB's primary mode of action is physical dilatation of the vessel lumen by percutaneous transluminal angioplasty (PTA) , followed by the delivery of paclitaxel. (dicardiology.com)
demonstrated that the superiority of Drug-Coated Balloon (DCB) versus percutaneous transluminal angioplasty (PTA) in the efficacy of femoropopliteal artery disease (FPAD) treatment persists at 24-month follow-up. (cardiologynownews.org)

The Passeo-18 Lux Drug-Coated Balloon is indicated to dilate de novo or restenotic lesions in the infrainguinal arteries* through a low profile** balloon platform. (biotronik.com)
Femoropopliteal artery lesions treated with the Ranger paclitaxel-coated balloon from Boston Scientific had less late lumen loss compared with lesions treated with uncoated balloons (-0.16 mm versus 0.76 mm, P =0.0017). (medpagetoday.com)
Patients were enrolled if they had de novo lesions with a visual estimation of lumen DS of 50-70% and without revascularization (balloon angioplasty and/or stent implantation) after IVUS examination. (hindawi.com)
The drug helps prevent neointimal hyperplasia (scar tissue growth) caused by trauma when the vessel segment is treated for atherosclerotic lesions with balloon angioplasty. (researchandmarkets.com)
Albrecht and co-authors surmise that "Our results suggest that all patients and lesions benefit to a similar degree from the use of drug-coated balloons. (vascularnews.com)
The approval of the In.Pact Admiral 200mm and 250mm balloons provides physicians with a solution to treat these long, complex lesions with fewer devices, potentially leading to shorter procedure times and reduced procedural cost. (dicardiology.com)
[ 1 , 2 ] The device is coated with paclitaxel and intended for use to treat stenotic or obstructive lesions in the femoropopliteal arteries to improve limb perfusion. (medscape.com)

NOVEMBER 4, 2022) Professor of Surgery and UVMMC vascular surgeon Daniel J. Bertges, M.D., presented a clinical trial on paclitaxel drug-coated balloons (DCBs) at the VIVA Foundation's VIVA22 conference in Las Vegas, according to CardiovascularBusiness.com. (uvm.edu)
Both groups are testing drug-coated balloons (DCBs) in PAD patients. (tctmd.com)

Of the future of paclitaxel-coated devices, Albrecht is cautiously optimistic, admitting that further investigations are needed, but also emphasising the historic safety and efficacy of these drug-coated devices. (vascularnews.com)
A randomized global, prospective, multi-center, single-blind trial comparing the Eluvia paclitaxel-eluting stent (Boston Scientific) to Zilver PTX paclitaxel-eluting stent (Cook Medical) has shown that the Eluvia stent outperformed Zilver in terms of efficacy, which was defined as primary patency at 12 months. (cardiologynownews.org)

For instance, in October 2019, Koninklijke Philips N.V., a health technology company, launched two new Stellarex Drug-Coated Balloon Sizes. (researchandmarkets.com)

BIOTRONIK's Lux ® coating provides a hydrophobic BTHC excipient, which is less soluble than hydrophilic alternatives, ensuring more drug is available at the lesion site. (biotronik.com)

A pooled analysis of four randomised controlled trials finds drug-coated balloon (DCB) angioplasty superior to plain angioplasty in patients with femoropopliteal artery disease, irrespective of their demographics, cardiovascular risk factors, comorbidities or lesion characteristics. (vascularnews.com)

The SafeGuard ® Insertion Aid reduces drug loss in the introducer sheath up to 94% and protects user and balloon from contact and damage, while the Lux ® Coating (Paclitaxel and BTHC) optimizes drug transfer and ensures high drug retention at the lesion site. (biotronik.com)
Effective drug delivery to the lesion with SafeGuard ® insertion aid and the hydrophobic BTHC excipient as part of the Lux ® Coating. (biotronik.com)

Stellarex drug-coated balloon featuring EnduraCoat technology comprising hybrid coating, Polyethylene glycol (PEG) excipient and 2µg/mm² low drug dose. (philips.hu)
We need to remember that every device each has its own unique paclitaxel dose, formulation, and distinct excipient, and as such it needs to be put to the test under the most stringent conditions," Katsanos continued. (tctmd.com)
The excipient is a crucial part of a drug-eluting balloon, as it may have a direct effect on the drug uptake. (l2mtech.de)

Market participants are focusing on developing affordable, precise, and efficient drug-eluting/drug-coated balloon catheters to improve medication delivery. (grandviewresearch.com)
Over the projection period, this effort will boost the market expansion of drug-eluting/drug-coated balloon catheters. (grandviewresearch.com)

By combining simple and effective balloon dilation with localized delivery of a proven antiproliferative drug² - The Optilume® Urethral Drug Coated Balloon provides long-term relief from stricture recurrence¹. (laborie.com)
Stellarex is the only low-dose drug-coated balloon with a proven treatment effect at three years compared to the existing standard-of-care in the U.S. and Europe. (philips.com)
1) The Nellix endovascular aneurysm sealing system and Paclitaxel coated balloons were withdrawn from use due to proven patient safety issues. (vascularsociety.org.uk)

Drug eluting balloons are angioplasty balloons that are coated with an anti-proliferative drug, which is eluted in vessel walls during the inflation of balloon, usually at nominal pressure with a specific minimal inflation time. (researchandmarkets.com)

Moreover, we continue to see no significant difference in mortality rates between patients treated with Stellarex and those treated with uncoated balloons, which confirms our confidence in the safety profile of Stellarex. (philips.com)

The ILLUMENATE Pivotal trial results show that at 36 months, 64.2% of the patients treated with Stellarex maintained blood flow through the treated segment of the diseased artery, compared to 51.0% of the patients treated with an uncoated balloon, demonstrating continued durability of the procedure. (philips.com)
The ILLUMENATE EU RCT results show that at 36 months, 67.5% of the patients treated with Stellarex maintained blood flow (assessed through blinded core-lab adjudicated patency), compared to 59.9% of the patients treated with an uncoated balloon. (philips.com)
The EU RCT showed mortality rates of 9.4% for patients treated with Stellarex, compared to 8.5%for patients treated with an uncoated balloon. (philips.com)
Royal Philips introduced two new balloons to its Stellarex 0.035" low-dose drug-coated balloon (DCB) portfolio. (researchandmarkets.com)

Why Butyryl-tri-hexyl citrate (BTHC) coating? (l2mtech.de)

Rapid uptake of the highly lipophilic drug, paclitaxel, limits hyperactive cell proliferation and the fibrotic scar tissue generation that results in stricture recurrence. (laborie.com)
The active substance coated on the drug eluting balloon should be lipophilic in nature to have a high absorption rate through the vessel wall. (researchandmarkets.com)

All the balloons used across these trials were coated with the same dose of paclitaxel (3µg/mm2). (vascularnews.com)

The results were evaluated compared to treatment with uncoated balloons, the current standard of care. (philips.com)
Through three years, both studies showed no significant difference in mortality compared to treatment with uncoated balloons. (philips.com)
While mortality rates for the two types of treatment were similar at 1 year, there was a 68% relative risk increase in all-cause death with paclitaxel-coated devices at 2 years and a 93% relative risk increase by 5 years compared with an uncoated-balloon approach. (tctmd.com)

Explaining these contradictory results, Albrecht elucidates: "We did not see a significant influence of paclitaxel coated balloons on mortality [like Katsanos et al did]. (vascularnews.com)

The balloons carry an antiproliferative drug that is delivered to the wall of arteries when the balloon is expanded. (researchandmarkets.com)

The factors such as rise in demand for minimally invasive procedures and innovations in drug-coated/drug-eluting balloons are expected to contribute to growth of the market. (grandviewresearch.com)
Drug-coated/drug-eluting balloons can treat and correct these problems. (grandviewresearch.com)
The aforementioned factors are therefore expected to increase consumer demand for drug-coated/drug-eluting balloons. (grandviewresearch.com)
Mostly paclitaxel is used as active ingredient due to its high pharmacokinetic transfer rate into the vessel wall and it is actively used in drug eluting balloons in the U.S. market and has been already approved for use in Europe. (researchandmarkets.com)

As long as there are no safety concerns from the study monitors, I personally believe that all clinical studies need to continue, as they may provide invaluable evidence to decide on the safety and effectiveness of paclitaxel treatments in general. (tctmd.com)

In addition, there are several studies of paclitaxel-coated devices already running for other indications in other vascular fields (eg, below-knee vessels for critical limb ischemia, failing shunts in hemodialysis, etc). (tctmd.com)

In this analysis, led by Dr. Eva Freisinger published in the European Heart Journal , the investigators offer evidence that conflicts with the data that suggests paclitaxel-based DED is associated with increased mortality risk. (cardiologynownews.org)

Larger prospective studies are needed to assess how a PCB would perform when compared to a non-drug coated balloon. (elsevierpure.com)

Very compliant balloon with homothetic inflation Which use out of scope? (bifurc.eu)

Prof Marianne Brodmann (Medical University of Graz, AT) discusses safety of pacilitaxel coated balloons. (radcliffecardiology.com)
1. There have been safety concerns with paclitaxel DCB's. (radcliffecardiology.com)
In the first two studies, the BCD was more effective than conventional balloon angioplasty and had comparable safety. (medscape.com)

Outcomes after PCI with a bioabsorbable polymer-coated, everolimus-eluting coronary stent in patients with diabetes: three-year results from the EVOLVE II diabetes substudy: Martine Gilard, M.D., will present at 11:35 in the Maillot room. (bostonscientific.com)
There was no significant difference in amputation rate between the two groups: 2.3% for the plain angioplasty treated patients vs. 2.8% in the paclitaxel-coated balloon cohort (p=0.742). (vascularnews.com)

Anatomy9

Organisms3

Diseases30

Chemicals and Drugs33

Analytical, Diagnostic and Therapeutic Techniques and Equipment48

Phenomena and Processes14

Disciplines and Occupations1

Technology, Industry, Agriculture3

Information Science1

Health Care9

Catheter10

Stents7

Restenosis11

Peripheral13

Percutaneous5

Lesions7

DCBs2

Efficacy2

20191

Less soluble than hydrophilic alternatives1

Femoropopliteal artery1

Lesion2

Excipient3

Catheters2

Proven3

Angioplasty balloons1

Treated with uncoated balloons1

Stellarex4

BTHC1

Lipophilic2

Trials1

Treatment3

Katsanos1

Arteries1

Drug-eluting4

Treatments1

Vessels1

Mortality risk1

Prospective1

Inflation1

Safety3

Patients2