iVascular’s Essential Pro Drug-Coated Balloon Launched Globally

June 17, 2020—iVascular SLU announced the global launch of the Essential Pro drug-coated balloon (DCB). Essential Pro is indicated for the dilatation of stenosis or coronary artery or bypass graft occlusions, including small vessels, as well as for residual stenosis after treatment with balloon or endoprosthesis and pre- and postdilation of coronary endovascular prosthesis.

According to the company, the Essential Pro incorporates platform improvements from its predecessor, including:

• An increase of the inflation channel and the availability of two different shafts to provide fast deflation times.
• An improved transition lumen structure that transmits the whole push to the distal shaft, as well as uniform transmission allowed by a new straight distal dual-layer shaft design without welds.
• Metallic radiopaque markers for improved visibility.
• Hydrax Plus, the company’s hydrophilic coating technology, applied in the distal shaft, which reduces friction during navigation for improved trackability.

iVascular advised that its technology is supported by clinical studies evaluating the Essential device in treating small vessels and in-stent restenosis.

The Essential in Small Vessels registry is an international, multicenter, prospective, observational registry of percutaneous coronary intervention for treating de novo lesions in small coronary vessels with the Essential device. Baseline characteristics showed a very small diameter of reference (< 2.5 mm) and high-risk patients (56% diabetics), with only a 12.7% of bailout stenting. In the registry’s primary endpoint, the Essential device showed a 4.2% target lesion failure rate at 12 months. In the secondary endpoint, there was a 9.9% rate of major adverse cardiac events at 12 months.

The investigator-initiated, observational, prospective, multicenter Essential In-Stent Restenosis study showed that drug-eluting stent restenosis was treated in 67% of the cases, and 94% DCB angiographic success was achieved with only two additional stentings. For the primary endpoint, the Essential device showed a 51.4% in-segment maximal area stenosis at 6 months. For the secondary endpoint, target lesion failure was 13.3% at 24 months.