January 28, 2021
SIS Medical AG manufacturer and distributor of high-quality and high-performance products in the field of interventional cardiology, announces the successful completion and publication of the ISAR-CALC study (“ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions”) for its OPN-NC Super High-Pressure PTCA Balloon for the treatment of calcified and highly calcified coronary stenosis.
As part of this multicentric, randomized, open-label trial, 74 patients with severely calcified lesions were enrolled in five clinics in Germany, Deutsches Herzzentrum München, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Herzzentrum Segeberger Kliniken in Bad Segeberg, Herzzentrum Leipzig at the University of Leipzig, and Switzerland (Herzzentrum Luzerner Kantonsspital), and treated with different types of balloons.
The primary endpoint of the study was to compare the effects of the different types of balloons on stent expansion as assessed by optical coherence tomography (OCT), while the secondary endpoints included angiographic, strategic, and procedural success.
The results of the study show that in comparison to scoring balloons, the Super High-Pressure Balloon achieved comparable and even improved stent expansion with more frequent strategic and procedural success, increased lumen diameter, reduced diameter stenosis, and a significantly reduced need to use additional devices in order to complete the treatment.
Scoring balloons have a generally lower pressure resistance of 14 to 18 atm and a compliance which lies between semi-compliant and low-compliant balloons. When used, the wire-like metallic or polymer structure wrapped around the balloon is pressed into the calcified coronary wall with the aim of weakening calcium deposits.
In the next step, the weakened calcium is broken up by using an additional non-compliant balloon. This increases both procedural costs and time, which also increases the risk for the patient. Based on the study results, the same effect can be achieved in a single step by applying the OPN-NC Super High-Pressure Balloon with all the potential advantages as demonstrated by the study results.
The OPN-NC balloon features unique patented double balloon technology by SIS Medical AG, providing a pressure resistance of over 30 atm with a very low compliance, which allows it to break up calcium deposits without over-dilating the blood vessel. The study shows the latter as being one of the key advantages of the OPN-NC, as more lumen gain is achieved in the artery and minimal lumen diameter is increased significantly. This is an important factor in preventing future cardiac events. Another advantage lies in reduced stenosis diameter, which decreases the likelihood of re-interventions being necessary in the future, effectively improving patient quality of life.
“Compared to scoring balloons at lower pressures, the OPN-NC Super High-Pressure Balloon shows improved efficacy and safety, which often constitutes a major issue in the treatment of calcified lesions. During the ISAR-CALC study, the test group for the OPN-NC Super High-Pressure Balloon experienced no major adverse cardiac events at the 30-day mark. This confirms the safety profile of the OPN-NC balloon in daily practice”, says Heinz Joachim Büttner M.D., Member of the Medical Advisory Board of SIS Medical AG, former Head of Interventional Cardiology at Universitäts-Herzzentrum Freiburg-Bad Krozingen, and Founding Member of the EuroCTO Club.
“The successful completion of the ISAR-CALC study is an important milestone in the short history of SIS Medical AG and the excellent results allow us to position our OPN-NC super high-pressure balloon as an effective alternative solution for indications in which scoring balloons are used today, or in all other cases of calcified or highly calcified lesions, in which an appropriate alternative interventional instrument is simply not available today. With this solid clinical data, we are well-prepared not only to compete with the scoring balloons of renowned manufacturers worldwide but also to promote our Super High-Pressure Balloon as an effective, safe, and economically preferable solution”, says Sergej Kammerzell, CEO of SIS Medical AG.
“The study results will certainly have a significant positive impact on increasing the adoption of the OPN-NC balloon in the field and support our registration and reimbursement strategy in a number of key markets, such as the US, China and Japan”, adds Willi Zwahlen, Senior Vice President of Sales, Co-Founder and Board Member of SIS Medical AG.
“The potential market for the OPN-NC super high-pressure balloon includes interventions in all stenotic calcified and highly calcified coronary arteries as well as in-stent restenosis cases, which add up to approximately one million annual procedures worldwide, with an estimated potential turnover of about USD 500 million per year”, says Hubertus Leonhardt, Chairman of the Board of SIS Medical AG and Managing Partner of Tübingen-based medical technology investor SHS Beteiligungsmanagement mbH.
The complete ISAR-CALC study has been published and is available on EuroIntervention Journal, DOI:10.4244/EIJ-D-20-01000.