CLINICAL EVIDENCE – SIS Medical AG

Click to read SCAI guidelines for ISR

1. SCAI Expert Consensus Statement on Management of In-Stent Restenosis and Stent Thrombosis

Klein, Lloyd W. et al.

Journal of the Society for Cardiovascular Angiography & Interventions, Volume 2, Issue 4, 100971

July-August 2023

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Click to read SCAI guidelines for calcified lesions

2. SCAI Expert Consensus Statement on the Management of Calcified Coronary Lesions

Riley, Robert F. et al.

Journal of the Society for Cardiovascular Angiography & Interventions, Volume 3, Issue 2, 101259

February 2024

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In-Stent Restenosis

For ISR treatment, using the super non-compliant OPN NC balloon at very high pressures is safe.

Calcium toolbox

OPN optimizes stent malapposition

ISAR-CALC Trial

In patients with severely calcified coronary artery lesions, preparation with a super high-pressure balloon versus a scoring balloon was associated with comparable stent expansion on intravascular imaging and a trend towards improved angiographic performance.

Rotational Atherectomy or Balloon

In patients with severely calcified lesions undergoing drug-eluting stent implantation, lesion preparation with RA, MB, or a super high-pressure balloon was associated with comparable stent expansion.

OCT guided registry with OPN NC

Among patients with heavy calcified lesions undergoing OCT guided intervention with OPN NC, acceptable expansion was achieved in most cases without procedure related complications.

Resistant Coronary lesions

The OPN-dedicated high-pressure balloon provides an effective and safe strategy for treatment of severe resistant coronary lesions.

Safety and Efficacy of OPN Balloon

OPN balloon is safe, and effective in treating calcified coronary lesions.

High-pressure balloon for undilatable lesions

The very high-pressure NC balloon was shown to be an effective and safe tool for optimal lesion preparation and stent deployment, even when other technologies have failed to achieve adequate results.

Successful dilatation of underexpanded stent with OPN

OPN is your ultimate solution for underexpanded stents in presence of calcium.

OPN for a non-dilatable in-stent restenosis

OPN obtains excellent stent expansion of the double-layered stents in ISR .

Experience With OPN NC PTCA Treating Complex Coronary Lesions

The OPN very high-pressure balloon is effective and safe for optimizing lesion preparation in complex calcified coronary artery disease.

Combination of Laser Atherectomy and OPN Balloon to Treat Stent Under-expansion in Cases of Failed Interventional Options

Considering the available data presented the authors strongly believe in the use of ELCA followed by OPN NC for treatment of severe stent under-expansion. The use of intravascular imaging, specifically OCT, is highly recommended in stent under-expansion treatment.

OPN dilatation for undilatable coronary lesions: indications and results with a new dedicated balloon

OPN NC super high-pressure balloons can provide an effective strategy for treatment of severely calcified coronary lesions. .

Optical coherence tomography-guided management of underexpanded stent in calcified coronary lesion

OPN might be used as the first line of treatment in cases of stent underexpansion. .

Successful Dilation of a Heavily Calcified LAD With 3 Layers of Under-Expanded Stents With the OPN NC

In this case, we felt use of the OPN NC was the best option.

Super-High–Pressure Balloons

The OPN NC balloon represents a significant advancement in interventional cardiology, offering a versatile solution for highly calcified and nondilatable lesions. With its dual-layer construction and remarkable resistance to high pressures, it shows promise as a valuable tool in select cases, with low rates of dissections and perforations. Continued device refinements and wider adoption will be crucial to enhancing its efficacy and expanding its applicability in managing complex coronary lesions.

Current Management of Highly Calcified Coronary Lesions: An Overview of the Current Status

MLD and acute gain were significantly greater and %DS was significantly lower post OPN NC balloon compared with conventional NC balloon inflation

Contemporary approach to heavily calcified lesions: tools of the trade, challenges, and pitfalls

Contrary to common opinion, the risk of perforation using OPN balloons is low

Why do you need OPN in every cathlab?

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Interviews with Prof. Dr. Florim Cuculi. Head of Cardiology Heart Centre Lucerne, Switzerland