A novel constrained, paclitaxel-coated angioplasty balloon catheter

Cremers, Bodo; Binyamin, Gary; Clever, Yvonne P.; Seifert, Paul S.; Konstantino, Eitan; Kelsch, Bettina; Bienek, Stephanie; Speck, Ulrich; Scheller, Bruno

doi:10.4244/eij-d-16-00093

Cited by 10 publications

(9 citation statements)

References 26 publications

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“…However, embolization to the myocardium would result in immediately detectable and persistent functional deficits, which were not seen even at high overdose in animal experiments. [21][22][23][24] Clinical experience in hundred thousand of critically ill patients and the experience especially in coronary trials confirm that no consequences may be expected. [25][26][27] Finally, DCB have been used in intracranial vessels without causing neural deficits.…”

Section: Discussionmentioning

confidence: 99%

Preclinical Evaluation of the Temporary Drug-Coated Spur Stent System in Porcine Peripheral Arteries

Brunacci¹,

Schurmann-Kaufeld²,

Haase

et al. 2021

J Endovasc Ther

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Background: Drug penetration into the deeper arterial wall of heavily calcified lesions is one of the limitations of drug-coated balloons and drug-eluting stents in vascular interventions. The Temporary Spur Stent (TSS) system is characterized by a self-expanding nitinol stent that is uniformly covered in radialspikes, which, when coated, should allow a deeper penetration and longer retention of the drug into the diseased artery walls by penetrating through the calcified plaques. Materials and Methods and Results: Uncoated TSS and paclitaxel (PTX)-coated TSS systems have been deployed in porcine peripheral arteries. Four weeks after the deployment of uncoated TSS systems, no adverse vascular remodeling or neointimal formation in the treated vessel segments were noticed. PTX-coated TSS systems transferred 9%±7% of the drug that was on the device to the targeted vessel area (196±163 ng PTX/mg arterial tissue) and the addition of the fluorescent dye Nile red to the coating showed that the spikes promote the transfer of the coating to the deeper layers of the vessel wall. The PTX-coated TSS systems showed a significant reduction in neointimal proliferation compared to the uncoated TSS systems: quantitative angiography showed a vessel diameter stenosis of 37.2%±11.0% and 16.4%±8.8% 4 weeks after the treatment with uncoated and PTX-coated TSS systems, respectively. Conclusion: The treatment with the TSS system was well tolerated and the spikesfacilitate the transfer of the coating into deeper layers of the vessel wall. Moreover, the PTX-coated TSS systems effectively inhibit neointimal proliferation.

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Section: Discussionmentioning

confidence: 99%

Preclinical Evaluation of the Temporary Drug-Coated Spur Stent System in Porcine Peripheral Arteries

Brunacci¹,

Schurmann-Kaufeld²,

Haase

et al. 2021

J Endovasc Ther

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“…(b) Available data on endovascular treatments are based on case reports or case series with low patients numbers. The underlying evidence has changed since and with the nitinol‐structured (chocolate‐like) drug‐coated (paclitaxel) balloon technology (C‐DEB PTA), new technology has become available . A literature search on PubMed performed on September 23rd 2018 revealed only eight references based on the keywords “chocolate” and “balloon.” In combination with “Takayasu,” no reference is left.…”

Section: Discussionmentioning

confidence: 99%

“…A combination of either treatment strategy has been recently become available which is a paclitaxel‐covered balloon and constrained by a nitinol structure that creates pillows and grooves in the balloon. It also provides fast deflation and uniform rewrap (chocolate drug‐eluting PTA balloon catheter (C‐DEB PTA) . In this case report, we describe—to the best of our knowledge—the first successful percutaneous transluminal angioplasty with a nitinol‐structured (chocolate‐like) drug‐coated (paclitaxel) balloon technology (C‐DEB PTA) in a patient with TA.…”

Section: Introductionmentioning

confidence: 97%

“…It also provides fast deflation and uniform rewrap (chocolate drug-eluting PTA balloon catheter (C-DEB PTA). [8][9][10][11] In this case report, we describe-to the best of our knowledge-the first successful percutaneous transluminal angioplasty with a nitinol-structured (chocolatelike) drug-coated (paclitaxel) balloon technology (C-DEB PTA) in a patient with TA.…”

Section: Introductionmentioning

confidence: 99%

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Recanalization of bilateral axillaris/brachialis artery occlusion in a patient with Takayashu arteritis: First case report on using a novel drug‐coated nitinol “chocolate” balloon catheter

Leigh

Kor

Czantrak

et al. 2018

Clinical Case Reports

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“…In particular, at the stent edge where vessel compliance can change drastically, PSVR might be inconsistent. Furthermore, in parallel with the development of new devices, it remains unclear whether downstream effect of drug particles or excipient from drug-eluting devices can affect flow velocity [28], and a late lumen loss after the use of drug-eluting device might be an ongoing dynamic process. We emphasize the need for recognizing the drawbacks of PSVR when applying and interpreting DUS in clinical trials and clinical practice.…”

Section: Drawbacks Of Psvrmentioning

confidence: 99%

Peak systolic velocity ratio derived from quantitative vessel analysis for restenosis after femoropopliteal intervention: a multidisciplinary review from Endovascular Asia

Kawarada

Hozawa

Zen

et al. 2019

Cardiovasc Interv and Ther

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With technological improvements in the endovascular armamentarium, there have been tremendous advances in catheterbased femoropopliteal artery intervention during the last decade. However, standardization of the methodology for assessing outcomes has been underappreciated, and unvalidated peak systolic velocity ratios (PSVRs) of 2.0, 2.4, and 2.5 on duplex ultrasonography have been arbitrarily but routinely used for assessing restenosis. Quantitative vessel analysis (QVA) is a widely accepted method to identify restenosis in a broad spectrum of cardiovascular interventions, and PSVR needs to be validated by QVA. This multidisciplinary review is intended to disseminate the importance of QVA and a validated PSVR based on QVA for binary restenosis in contemporary femoropopliteal intervention.

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A novel constrained, paclitaxel-coated angioplasty balloon catheter

Abstract: The results demonstrate efficacy and tolerance of a mechanically unique constrained angioplasty balloon within the tested dose range of the selected paclitaxel coating in the chosen porcine preclinical model.

Cited by 10 publications

References 26 publications

Preclinical Evaluation of the Temporary Drug-Coated Spur Stent System in Porcine Peripheral Arteries

Preclinical Evaluation of the Temporary Drug-Coated Spur Stent System in Porcine Peripheral Arteries

Recanalization of bilateral axillaris/brachialis artery occlusion in a patient with Takayashu arteritis: First case report on using a novel drug‐coated nitinol “chocolate” balloon catheter

Peak systolic velocity ratio derived from quantitative vessel analysis for restenosis after femoropopliteal intervention: a multidisciplinary review from Endovascular Asia

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