The study's findings indicate that, relative to balloons, the Super High-Pressure Balloon achieved equivalent and even better stent expansion.
FREMONT, CA: SIS Medical AG (Swiss Interventional Systems), a leading producer, manufacturer, and distributor of high-quality and high-performance devices in the area of interventional cardiology, announced the successful completion and release of the ISAR-CALC analysis (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.
"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, SIS Medical AG.
In this multicenter, randomized, open-label study, 74 patients with strongly calcified lesions were enrolled in five clinics in Germany's Deutsches Herzzentrum M1⁄4nchen, Universitats-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 distinct types of balloons. The analysis's primary endpoint was to compare the results of the various types of balloons on stent expansion as measured by optical consistency tomography (OCT). In contrast, the secondary endpoints included angiographic, strategic, and procedural performance.
The study's findings indicate that, relative to balloons, the Super High-Pressure Balloon achieved equivalent and even better stent expansion. It had more regular strategic and procedural performance, increased lumen diameter, decreased stenosis diameter, and dramatically reduced need for additional instruments to complete the procedure.
"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, SIS Medical AG.
Scoring balloons usually have a lower pressure tolerance of 14 to 18 atm and conformance between semi-compliant balloons and low-compliant balloons. As used, the wire-like metallic or polymer structure wound around the balloon is pressed against the calcified coronary wall to weaken the calcium deposits.
In the next step, the depleted calcium is broken up by using an external non-compliant balloon. This instance raises both procedural costs and time, which also increases the risk to the patient. Based on the study results, the same effect can be accomplished in a single step by applying the OPN-NC Super High-Pressure Balloon with all the possible advantages as shown by the results of the study.
"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 B¼ttner M.D., Member of the Medical Advisory Board of SIS Medical AG, former Head of Interventional Cardiology at Universitats-Herzzentrum Freiburg-Bad Krozingen, and Founding Member of the EuroCTO Club.
The OPN-NC balloon uses unique proprietary double balloon technology by SIS Medical AG, offering a pressure resistance of more than 30 atm at a very low altitude, allowing calcium deposits to be broken down without over-dilating the blood vessel. The research indicates that this is one of the main benefits of the OPN-NC since more lumen gain is obtained in the artery, and the minimum lumen diameter is much improved. This is an essential element in the avoidance of potential heart events. Another benefit is the decreased stenosis diameter, which lowers the probability that re-interventions will be performed in the future and will enhance patient quality of life efficiently.
"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 T¼bingen-based medical technology investor SHS Beteiligungsmanagement mbH.