IN.PACT™ Admiral™ drug-coated balloon: Durable, consistent and safe treatment for femoropopliteal peripheral artery disease

Peterson, Susan Rea; Hasenbank, Melissa S.; Silvestro, Claudio; Raina, Shashank

doi:10.1016/j.addr.2016.10.003

Cited by 19 publications

(17 citation statements)

References 67 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Currently, DCBs are coated with the antiproliferative agent paclitaxel, which transfers to the inner arterial wall on inflation and may persist in the vessel tissue for up to 180 days. [1][2][3] Numerous randomized controlled trials (RCTs) have demonstrated that DCBs are safe and more effective for the treatment of patients with femoropopliteal lesions than uncoated balloon angioplasty (IN.PACT SFA, LEVANT 2, BIOLUX P-1, THUNDER, ILLUMENATE EU, ILLUMENATE Pivotal). [4][5][6][7][8][9][10] Meta-analyses of clinical trials have also shown that DCBs are a cost-effective option that provides clinically meaningful benefit compared with traditional non-drug-based treatments, such as bare metal stents or angioplasty with an uncoated balloon.…”

Section: Introductionmentioning

confidence: 99%

Drug-Coated Balloon Treatment of Femoropopliteal Lesions Typically Excluded From Clinical Trials: 12-Month Findings From the IN.PACT Global Study

Ansel

Brodmann

Keirse³

et al. 2018

J Endovasc Ther

View full text Add to dashboard Cite

Purpose: To report a post hoc analysis comparing outcomes between subjects who would have been included in the IN.PACT SFA randomized controlled trial vs those who would have been excluded. Methods: The 1406 subjects enrolled in the IN.PACT Global Study (ClinicalTrials.gov identifier NCT01609296) were retrospectively assigned to a standard-use group (n=281) based on the inclusion and exclusion criteria from the randomized IN.PACT SFA trial; the remaining 1125 patients were assigned to the broader-use group. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated at 12 months. The composite primary safety endpoint was freedom from 30-day device- and procedure-related death plus freedom from 12-month target limb major amputation and clinically-driven target vessel revascularization (CD-TVR). Functional outcomes were evaluated with dedicated questionnaires. Results: Compared with the standard-use cohort, the broader-use lesions were longer, more calcified, and had more popliteal involvement, bilateral disease, and in-stent restenosis (p<0.001 for all). Freedom from 12-month CD-TLR by Kaplan-Meier analysis was 96.6% for the standard-use group and 91.6% for the broader-use group (p=0.005). The safety endpoint was 96.2% in the standard-use group and 91.0% in the broader-use group (p=0.003). The 12-month CD-TLR (3.4% standard-use vs 8.5% broader-use, p=0.004) and CD-TVR (4.2% standard-use vs 9.1% broader-use, p=0.008) were increased in the broader-use group. Twelve-month all-cause mortality was not increased (3.8% standard-use vs 3.4% broader-use, p=0.852). Conclusion: Post hoc analysis of the IN.PACT Global Study of real-world patients demonstrated consistent outcomes with significant clinical improvement to 12 months in subjects with complex lesions typically excluded from a randomized controlled trial.

show abstract

Section: Introductionmentioning

confidence: 99%

Drug-Coated Balloon Treatment of Femoropopliteal Lesions Typically Excluded From Clinical Trials: 12-Month Findings From the IN.PACT Global Study

Ansel

Brodmann

Keirse³

et al. 2018

J Endovasc Ther

View full text Add to dashboard Cite

show abstract

“…Obviously even more differences exist across the two platforms. [17][18][19][20] Finally, the aforementioned clinical studies have informed and populated multiple meta-analyses that confirmed and reinforced DCB/DES efficacy compared to their bare balloon/stent counterparts. 15,16,[21][22][23] With all this in mind, we acknowledge the recent work by Katsanos et al 24 The article, published in the Journal of the American Heart Association in December 2018, is a systematic review and meta-analysis of 28 randomized trials of paclitaxel-coated devices in the femoropopliteal arteries.…”

mentioning

confidence: 99%

Use of Paclitaxel-Eluting Technologies in the Femoropopliteal Segment Under Scrutiny Over Possible Link to Late All-Cause Mortality: Time to Panic or an Opportunity to Resurge?

2019

View full text Add to dashboard Cite

“…Moreover, the MR‐TMD‐DCB is designed for the treatment of multiple lesions with a single balloon. If a patient was treated for two lesions with the FDA approved IN.PACT DCB, two DCBs would be used, exposing the patient to 7 μg/mm 2 of PAT as a single IN.PACT DCB contains 3.5 μg/mm 2 PAT (Peterson, Hasenbank, Silvestro, & Raina, ). A study by Kelsch et al () also demonstrated a balloon coated with 9 μg/mm 2 PAT was tolerated well in porcine model with no adverse events.…”

Section: Discussionmentioning

confidence: 99%

Development of an automated micropipette coating method for drug‐coated balloons

et al. 2020

View full text Add to dashboard Cite

Drug-coated balloons (DCBs) are a recent technology developed to treat peripheral artery disease (PAD). Along with a suitable formulation of antiproliferative drug and excipient, coating method is an important aspect of a DCB as these factors affect coating characteristics and drug delivery to the treatment site. The multiple release tailored medical devices DCB (MR-TMD-DCB), designed to achieve multiple inflations to treat complex PAD, contains paclitaxel (PAT) as the antiproliferative drug and polyethylene oxide (PEO) as the excipient. In our previous studies, the MR-TMD-DCB was coated using a manual dip coating method. In this study, an automated micropipette coating method was developed using a modified spray coating instrument to coat the MR-TMD-DCB. First, the coating formulation and strategy was optimized. A drug formulation of 16 wt% PAT and 4% wt/vol PEO, a polymer formulation of 2.5% wt/vol PEO, and a total of two drug layers produced a mostly uniform and thin coating with no defects and acceptable drug load. The balloon also had optimal drug uptake in arterial tissue in an in vitro flow model. Next, the reproducibility of the coating strategy was improved by optimizing the instrument parameters. The optimized instrument parameters (translational speed = 0.150 in/s, revolution rate = 100 rpm, flow rate = 0.6 ml/min) resulted in improved reproducibility of the drug load and similar coating properties as the DCB. This study demonstrated the ability to automate the micropipette process to obtain a balloon with optimal coating properties and drug tissue uptake.

show abstract

IN.PACT™ Admiral™ drug-coated balloon: Durable, consistent and safe treatment for femoropopliteal peripheral artery disease

Cited by 19 publications

References 67 publications

Drug-Coated Balloon Treatment of Femoropopliteal Lesions Typically Excluded From Clinical Trials: 12-Month Findings From the IN.PACT Global Study

Drug-Coated Balloon Treatment of Femoropopliteal Lesions Typically Excluded From Clinical Trials: 12-Month Findings From the IN.PACT Global Study

Use of Paclitaxel-Eluting Technologies in the Femoropopliteal Segment Under Scrutiny Over Possible Link to Late All-Cause Mortality: Time to Panic or an Opportunity to Resurge?

Development of an automated micropipette coating method for drug‐coated balloons

Contact Info

Product

Resources

About