SIS Medical AG Welcomes the Results of the VICTORY Trial Demonstrating Non-inferiority of OPN NC to Intravascular Lithotrispy (IVL) for Lesion Preparation and Stent Expansion in Severely Calcified Lesions
SIS Medical AG, a Swiss manufacturer of the Super-High-Pressure PTCA balloon catheter (OPN NC), is pleased to announce that the results of the investigator-initiated VICTORY trial were presented during the late-breaking clinical session at TCT 2025 by the Cardiovascular Research Foundation (CRF). The randomized, multi-center clinical study was designed to compare the safety and efficacy between the OPN and IVL devices for lesion preparation and optimized stent expansion in highly complex calcified coronary lesions, deploying a drug-eluting stent (DES). Coronary artery calcium affects approximately one-third of patients undergoing PCI and is a key contributor to procedural and stent failure.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251105812157/en/
"With a similar safety profile, OPN can be a feasible and faster alternative to IVL." Dr. M. Bossard, Senior Physician at Luzerner Kantonsspital, Switzerland
A total of 282 patients at three sites in Switzerland and Canada were randomized one-to-one to IVL (n=142) and OPN (n=140). The primary endpoint was final stent expansion assessed by optical coherence tomography (OCT) determined by an independent imaging core laboratory. The OPN group achieved a median of 85.0% stent expansion compared to 84.0% in the IVL group, meeting non-inferiority (95% CI: 82.5-87.5, p<0.0001). The use of OPN resulted in similar rates of acute procedural (98.6% versus 97.1%) and strategy success (98.6% for both) compared with IVL. The results were consistent across all patient subgroups.
Additionally, OPN was equally safe to the IVL device regarding in-hospital MACE, coronary artery dissections and perforations, or side branch occlusions. “This study clearly shows that utilizing an OPN NC is non-inferior to IVL for OCT-guided lesion preparation and stent expansion in severely calcified lesions,” said Matthias Bossard, MD, Head of CHIP & CTO-PCI Program at Luzerner Kantonsspital Heart Center. “With similar safety profiles, the OPN NC can be a feasible and faster alternative to IVL.”
About the VICTORY clinical trial
VICTORY Trial – A randomized, multicenter, non-inferiority comparison of Shockwave Intravascular Lithotripsy (IVL) and the OPN non-compliant PTCA balloon for treatment of calcified and refractory coronary lesions (ClinicalTrials.gov ID NCT05346068).
About SIS Medical
SIS Medical AG, based in Frauenfeld, Switzerland, is specialized in developing, manufacturing and distributing cardiovascular products for interventional arterial diseases, offering specialty PTCA balloons for the treatment of complex calcified lesions. www.sis-medical.com
References
https://www.tctmd.com/news/trials-bolster-alternatives-intravascular-lithotripsy-calcified-lesions
View source version on businesswire.com: https://www.businesswire.com/news/home/20251105812157/en/
Contacts
Media Contact
Dr. Thomas Kraft, Phone: +41 52 245 09 90, Email: info@sis-medical.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
www.businesswire.com
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Quectel Unveils New Smart Single Board Computers (SBC) to Help Accelerate Intelligent Device Development, Rapid Prototyping and Cutting Development Costs5.11.2025 19:00:00 EET | Press release
Quectel Wireless Solutions, an end-to-end global IoT solutions provider, has launched three new smart single board computers (SBC). The QSM368Z, QSM560DR, and QSM668SR are designed to give developers more choice and speed up product development of intelligent solutions and digital transformation. Each board is cost-effective, fully certified, and offers a wide range of options for connectivity, operating system and memory options to suit different application needs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251105179097/en/ Quectel unveils new smart single board computers (SBC) to help accelerate intelligent device development, rapid prototyping and cutting development costs “These boards are fully finished hardware that can be easily integrated inside customers’ larger systems across a wide range of IoT use cases,” commented Raymond Wang, Head of Smart SoC, Quectel Wireless Solutions. “Provided in a ready-to-use, singl
First in Human Ischemic VT Ablation Successfully Performed in iCMR5.11.2025 17:55:00 EET | Press release
Imricor Medical Systems, Inc. (Company or Imricor) (ASX: IMR), together with Amsterdam University Medical Centre (Amsterdam UMC), is pleased to announce the successful completion of the first Ischemic Ventricular Tachycardia (VT) ablation ever performed under real-time MRI guidance in an iCMR lab. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251105120761/en/ Imricor’s NorthStar® Mapping System The Amsterdam UMC team, shown here, performed the VT ablation procedure following previous experiences performing atrial flutter and premature ventricular complex (PVC) ablation procedures guided by real-time MRI and Imricor’s NorthStar® Mapping System. Regarding the VT procedure, Dr. Kemme, stated: “This procedure is part of an international research programme. The MRI imaging shows us precisely where the myocardial infarction took place; therefore, we can send the catheter to the exact spot. This information can make ablation possi
Doha Debates Explores the Role of Ancient Wisdom in Today’s World5.11.2025 17:06:00 EET | Press release
As the world grapples with questions of meaning and moral direction, Doha Debates takes on a fundamental question: Should ancient wisdom guide today’s societies? This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251105183709/en/ Guest speakers and participating students gather on the Doha Debates stage to discuss a fundamental question “Should ancient wisdom guide today’s societies?” — part of the show’s exploration of timeless questions shaping our world today. (Photo: AETOSWire) In this episode of the new flagship season, moderated by Dareen Abughaida, students from across Qatar join three global thinkers to wrestle with a timeless dilemma: whether the answers to our most pressing problems lie in tradition or in bold new ideas. Wael Hallaq, Avalon Foundation Professor in the Humanities at Columbia University, critiques what he calls the “moral emptiness” of modernity and its fixation on material progress. He calls for a retur
Versa Delivers Proven Firewall Performance and Security Effectiveness Validated by Independent Testing5.11.2025 16:30:00 EET | Press release
Versa, the global leader in unified networking and security, today announced that its Next-Generation Firewall received CyberRatings.org’s highest “Recommended” rating for the ninth consecutive year. In the newly published Q3 2025 Enterprise Firewall report, based on independent testing by NSS Labs, Versa delivered 100% scores in critical categories like malware and exploit evasion resistance, and achieved a leading 7,626 Mbps rated throughput, over twice as fast as competing solutions. Selecting cybersecurity solutions requires unbiased, real-world performance testing and evaluation. CyberRatings.org provides IT and security leaders with data-driven results to guide investment decisions. In this latest assessment, Versa ranked among the top three vendors for Security Effectiveness and delivered more than twice the throughput performance, reinforcing Versa’s commitment to delivering industry-leading SASE protection and performance in every deployment. Download a copy of the CyberRating
Its Global Vision on Show, TVS Motor Company Makes a Stellar Debut at EICMA5.11.2025 16:16:00 EET | Press release
TVS Motor Company (TVSM) - a global leader in two and three-wheeler manufacturing - has taken centerstage at EICMA 2025, making a landmark debut at the world’s largest motorcycle exhibition. With a show floor commanding presence, TVS unveiled 6 new products across ICE and thermal powertrains, advanced ride assist gear including AR based Heads-Up display helmets, a stunning new range of accessories, connected technology that enhances rider-machine connect and its roadmap for expansion in Europe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251105242034/en/ TVS top leadership team posing with the global showcases at EICMA. From L to R: TVS M1-S, TVS X, TVS eFX three O, TVS RTX 300 and RTX 300 BTO, TVS Tangent RR Concept and RTR HyprStunt Concept. Commenting on TVSM’s maiden appearance at EICMA, Sudarshan Venu, Chairman, TVS Motor Company, said, “TVS is a business built over 100 years - a commitment to customer delight, quali
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom