June 19, 2020 — iVascular SLU announced the global launch of Essential Pro, a novel coronary artery drug-coated balloon (DCB).
The Essential Pro DCB presents several platform improvements from its predecessor such as:
• Superior safety with fast deflation times due to an increase of the inflation channel and the availability of two different shafts.
• Better pushability due to an improved transition lumen structure that transmits the whole push to the distal shaft, and uniform transmission due to a new straight distal dual layer shaft design without welds.
• Improved visibility with metallic radiopaque markers.
• Improved trackability due to Hydrax plus, iVascular proprietary hydrophilic coating technology. Hydrax plus is applied in the distal shaft, reducing friction during navigation.
The Eessential Pro is indicated for the dilatation of stenosis or coronary artery or bypass grafts occlusions, including small vessels, as well as for residual stenosis after treatment with balloon or endoprosthesis and pre- and post-dilation of coronary endovascular prosthesis.
Clinical Study in Small Vessels Using Drug-coated Balloon
An observational, prospective and multicenter registry in small vessels. Baseline characteristics showed a very small diameter of reference (<2.5mm) and high-risk patients (56% diabetics) with only a 12.7% of bailout stenting. In this registry, essential shows a 4.2% TLF at 12-months as a primary endpoint and 9.9% MACE at 12-month as a secondary endpoint. essential demonstrates to be a reliable alternative for small coronary vessels.
Essential DCB Use in Stent Restenosis
An investigator initiated, observational, prospective and multicenter study. DES restenosis was treated in 67% of the cases and a 94% of DCB angiographic success was achieved with only 2 additional stenting. In this study essential shows a 51.4% In-segment maximal area stenosis at 6-month as a primary endpoint and a 13.3% TLF at 24-month as a secondary endpoint. In this study, essential showed a good and sustained efficacy in the treatment of ISR (mostly of DES) maintained on the very long-term.
For more information: ivascular.global/coronary/essentialpro/
1. Rosa Alba Abellas-Sequeiros, Rodés-Cabau J., et al. Percutaneous Coronary Intervention for Treating De-Novo Lesions in Small Coronary Vessels: Initial Experience With the Essential Paclitaxel-Coated Balloon. Coronary Artery Disease. 29(6):477 481, September 2018.
2. J. De La Torre Hernández. Angiography and Optical Coherence Tomography Assessment of the Drug-Coated Balloon ESSENTIAL for the Treatment of In-Stent Restenosis. Cardiovasc Revasc Med. 2019 Jul 23. pii: S1553-8389(19)30433-6.