NIC Nano® hydro

Designed for Complex PCI: High Radial Force (35 atm RBP) to dilate coronary arteries in safe settings (highly non-compliant)

Technical Specifications

Clinical Studies

  • Super high-pressure balloon versus scoring balloon to prepare severely calcified coronary lesions: the ISAR-CALC randomised trial.

Rheude T, Rai H, Richardt G, Allali A, Abdel-Wahab M, Sulimov DS, Mashayekhi K, Ayoub M, Cuculi F, Bossard M, Kufner S, Xhepa E, Kastrati A, Fusaro M, Joner M, Byrne RA, Cassese S. EuroIntervention. 2021 Aug 27;17(6):481-488. doi: 10.4244/EIJ-D-20-01000.
PMID: 33258774 Free PMC article. Clinical Trial.

  • Treatment of In-Stent Restenosis Using a Dedicated Super High-Pressure Balloon.

Seiler T, Attinger-Toller A, Cioffi GM, Madanchi M, Teufer M, Wolfrum M, Moccetti F, Toggweiler S, Kobza R, Bossard M, Cuculi F.
Cardiovasc Revasc Med. 2023 Jan;46:29-35. doi: 10.1016/j.carrev.2022.08.018. Epub 2022 Aug 20.
PMID: 36085285

  • Editorial: Super High-Pressure Balloons: Where Do They Fit in the Calcium Toolbox? Kereiakes DJ.

Cardiovasc Revasc Med. 2023 Sep;54:31-32. doi: 10.1016/j.carrev.2023.02.019. Epub 2023 Mar 1.
PMID: 36925337 No abstract available.

  • Rotational Atherectomy or Balloon-Based Techniques to Prepare Severely Calcified Coronary Lesions.

Rheude T, Fitzgerald S, Allali A, Mashayekhi K, Gori T, Cuculi F, Kufner S, Hemetsberger R, Sulimov DS, Rai H, Ayoub M, Bossard M, Xhepa E, Fusaro M, Toelg R, Joner M, Byrne RA, Richardt G, Kastrati A, Cassese S, Abdel-Wahab M.
JACC Cardiovasc Interv. 2022 Sep 26;15(18):1864-1874. doi: 10.1016/j.jcin.2022.07.034. PMID: 36137691 Clinical Trial.

  • Treatment of Calcified Lesions Using a Dedicated Super-High Pressure Balloon: Multicenter Optical Coherence Tomography Registry.

Pinilla-Echeverri N, Bossard M, Hillani A, Chavarria JA, Cioffi GM, Dutra G, Guerrero F, Madanchi M, Attinger A, Kossmann E, Sibbald M, Cuculi F, Sheth T.
Cardiovasc Revasc Med. 2023 Jul;52:49-58. doi: 10.1016/j.carrev.2023.02.020. Epub 2023 Mar 2.
PMID: 36907698

  • Successful dilatation of underexpanded stent with super-high-pressure balloon: A case report. Jamakovic M, Aganovic K, Begic E.

Turk Kardiyol Dern Ars. 2020 Nov;48(8):766-770. doi: 10.5543/tkda.2020.00015.
PMID: 33257604 English.

  • A super high-pressure balloon solution for a non-dilatable in-stent restenosis.

Tanaka A, Jabbour RJ, Kawamoto H, Latib A, Colombo A.
Int J Cardiol. 2016 Jan 15;203:357-9. doi: 10.1016/j.ijcard.2015.10.188. Epub 2015 Oct 26. PMID: 26539956 No abstract available.

  • Clinical Experience with Very High-Pressure Dilatation for Resistant Coronary Lesions.

Secco GG, Buettner A, Parisi R, Pistis G, Vercellino M, Audo A, Kambis M, Garbo R, Porto I, Tarantini G, Di Mario C.
Cardiovasc Revasc Med. 2019 Dec;20(12):1083-1087. doi: 10.1016/j.carrev.2019.02.026. Epub 2019 Mar 1.
PMID: 30902652

  • Combination of Laser Atherectomy and Super High-pressure Non-compliant Balloon to Treat Stent Under-expansion in Cases of Failed Interventional Options.

Sasi V, Szántó G, Achim A, Ungi I, Varga A, Ruzsa Z.
Interv Cardiol. 2023 Jul 25;18:e23. doi: 10.15420/icr.2022.36. eCollection 2023.
PMID: 37538386 Free PMC article.

  • Very high-pressure dilatation for undilatable coronary lesions: indications and results with a new dedicated balloon.

Secco GG, Ghione M, Mattesini A, Dall’Ara G, Ghilencea L, Kilickesmez K, De Luca G, Fattori R, Parisi R, Marino PN, Lupi A, Foin N, Di Mario C.
EuroIntervention. 2016 Jun 20;12(3):359-65. doi: 10.4244/EIJY15M06_04.
PMID: 26111405

  • [Management of stent under-expansion]. Erriquez A, Pavasini R, Campo G.

G Ital Cardiol (Rome). 2020 Jun;21(6 Suppl 1):21S-26S. doi: 10.1714/3373.33489.
PMID: 32469341 Italian.

  • Modified balloons to prepare severely calcified coronary lesions before stent implantation: a systematic review and meta-analysis of randomized trials.

Scalamogna M, Kuna C, Voll F, Aytekin A, Lahu S, Kessler T, Kufner S, Rheude T, Sager HB, Xhepa E, Wiebe J, Joner M, Ndrepepa G, Kastrati A, Cassese S.
Clin Res Cardiol. 2024 Jul;113(7):995-1005. doi: 10.1007/s00392-023-02324-y. Epub 2023 Nov 6.
PMID: 37930402 Free PMC article. Review.

  • Randomized ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions 2:

Design and Rationale of the ISAR-CALC 2 Trial.
Scalamogna M, Abdel-Wahab M, Mashayekhi K, Fusaro M, Leistner DM, Ayoub M, Xhepa E, Joner M, Kastrati A, Cassese S, Rheude T.
Cardiovasc Revasc Med. 2023 Apr;49:22-27. doi: 10.1016/j.carrev.2022.12.008. Epub 2022 Dec 30.
PMID: 36609101 Clinical Trial.

  • When everything else fails: High-pressure balloon for undilatable lesions

Ioannis Felekos a, Grigoris V. Karamasis b, Antonis N. Pavlidis a

  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7839892/

Optical coherence tomography-guided management of underexpanded stent in calcified coronary lesion
Ankush Gupta,1 Sanya Chhikara,2 Navreet Singh,3 and Krishna Prasad4

  • https://www.hmpgloballearningnetwork.com/site/cathlab/case-report/successful-dilation-heavily- calcified-lad-3-layers-under-expanded-stents?s=08

Successful Dilation of a Heavily Calcified LAD With 3 Layers of Under-Expanded Stents With the OPN NC Super High-Pressure Balloon
Vikramjit Purewal , DO Raehan Ahmed , DO Chad F. Goerndt , RT(R) Nachiket J. Patel , MD

  • https://assets.bmctoday.net/citoday/pdfs/cit0524_F8_PCIBalloons.pdf

Optimizing PCI Specialty Balloon Use
Top tips for when and how to use drug-coated balloons, super-high–pressure balloons, and cutting and scoring balloons in percutaneous coronary intervention. With Pier Pasquale Leone, MD, MSc; Antonio Colombo, MD; Matteo Maurina, MD; Valeria Paradies, MD; Ottavia Cozzi, MD; Antonio Mangieri, MD; Gabriele Gasparini, MD; and Damiano Regazzoli, MD

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