March 21st, 2025
Exciting News: SIS Medical AG Achieves MDR (EU) 2017/745 Certification!
We are excited to announce that SIS Medical AG has successfully obtained full certification under the Medical Device Regulation (EU) 2017/745 (MDR)! The certification itself covers the Quality Management System as well as the Technical Documentation of all available SIS Medical products – OPN NC, NIC and EasyT. This significant milestone is a testament to our unwavering commitment to quality and safety in the medical device industry.
The MDR certification is a rigorous process that ensures our products meet the highest standards of quality and safety, aligning with the European Union’s stringent regulatory requirements. This achievement not only underscores our dedication to excellence but also reinforces our position as a trusted partner in the healthcare sector.
We are proud of our team’s hard work and perseverance, which have been instrumental in achieving this certification. This accomplishment will enable us to continue delivering exceptional medical devices that enhance patient care and outcomes.
What This Means for our Customers:
- Enhanced Product Safety: Our MDR certification enables that our products adhere to the most stringent European safety standards, providing you with confidence in the quality of our devices.
- Regulatory Compliance: We ensure full compliance with EU regulations and harmonised Standards, achieving seamless integration into your healthcare systems.
- Innovation and Excellence: This certification builds the foundation for our ongoing commitment to innovation and excellence in medical device technology.
We look forward to continuing to serve you with the highest level of quality and service. Thank you for your support and trust in SIS Medical!
December 19th, 2024
Best wishes for a happy holiday season from all of us at SIS Medical and our sincere thanks for your loyalty throughout the year.
We wish you a Happy, Healthy and Prosperous New Year and a wonderful holiday time!
Cheers to 2025!
November 24th, 2024
Nurnberg was the site of a fantastic DACH CTO&CHIP meeting 2024! It was an honor for SIS Medical to sponsor this event. We admire the CTO-PCI interventional cardiologists’ efforts to share their expertise and skills in order to improve the knowledge-sharing environment for complex PCI procedures.
Many thanks for the helpful guidance on CHIP and CTO interventions, as well as the session on managing complications.
With gratitude to PD Dr. Stylianos Pyxaras, Dr. Kambis Mashayekhi, Dr. Harald Rittger
Our team presented special PCI balloons
for your CTOtoolbox
NIC NANO
Hydro NC balloon 0.85 low profile for tight lesions and CTO
OPN NC
TwinWall balloon, Super-high pressure 35atm, designed for effective plaque modification
EasyT
High pressure balloon 21atm, effective for pre-dilation, post-dilation and POT
Protégé DCB
Wing Seal Technology ensures tight balloon wrapping for reduced crossing profile
Better preparation. Better treatment.
October 29th, 2024
SIS Medical hosted successfully a scientific symposium with more than 170 attendees about “The role of OPN NC in calcified coronary lesions” during the TCT congress 2024 in Washington DC, USA.
The faculty, led by Dr. Emmanouil Brilakis (Minneapolis, USA), and Dr. Florim Cuculi (Luzern, Switzerland) presented latest research and clinical cases targeting luminal gain in calcified lesions.
All speakers, Dr. Darshan Doshi (Boston, USA), Dr. Nachiket Patel (Mesa, USA), Dr. Stéphane Rinfret (Gainesville, USA), Dr. Natalia Pinilla (Hamilton, Canada), pointed out key success factors for an effective and safe calcium plaque modification:
(1) Using intravascular imaging to size the lumen gain,
(2) Defining the lesion strategy and having a device toolbox available for any intravascular adjustments,
(3) Seeking for PCI optimization whether it is after DES implantation with stent expansion or as lesion preparation for DCB.
OPN NC super-high pressure TWIN-wall balloon was summarized as an effective and safe device for in-stent restenosis, serve calcified lesions and stent expansion.
October 25th, 2024
SIS Medical is a proud sponsor of Academic Satellite Symposium during the TCT2024.
This event is an amazing opportunity to connect with physicians and innovators for a cutting-edge session, networking and more.
SIS Medical Satellite Symposium
📅 October 28th
10:30 a.m.
See full agenda and register: https://lnkd.in/eqTrgtXZ
This program is a live, in-person event and will take place at the meeting venue, the Walter E. Washington Convention Center (Washington DC, USA)!
September 5th, 2024:
SIS Medical was happy to sponsor the Swiss CTO&CHIP summit this year again. We greatly value the course directors Dr. Gregor Leibundgut & Dr. Daniel Weilenmann and all participant’s creativity and enthusiasm in addition to the amazing scientific program.
Seeing and reuniting with so many motivated, passionate and skilled CTO operators who committed their work to improving patient’s lives was a great pleasure!
We look forward to enjoying the new edition in 2025!
September 1st, 2024:
We proudly announce the appointment of Thomas Kraft, PhD. as Chief Executive Officer, effective September 2024.
Dr. Kraft will lead the company’s growth in the upcoming phase and elevate its expansion to the next international level.
Having worked in the MedTech sector for more than 20+ years on a global scale, Thomas brings to SIS Medical a track record of achieving both strategic growth and operational excellence. His background equips him uniquely to lead SIS Medical into its next successful chapter.
