Blog

Articles in Category: PTCA Balloons

Back on Track!

Like many other companies, we at SIS Medical are looking back on a challenging year. The COVID – 19 consequences did hit us significantly in terms of catheter usage and impacted our revenue. Especially during the first wave of the pandemic, in many countries the procedures in Interventional Cardiology were dramatically reduced. We reacted with the implementation of the “short time work” in our production for a period of 8 months. Logically, the limited access to the hospitals and travel restrictions led to a reduced contact to our clinical customers and distributors.

However, today we see the “light at the end of the tunnel”, the number of procedures has picked-up and our sales numbers look better than in 2020.

Second challenge after COVID – 19 was the change of our European Notified Body. The entire SIS Medical Team was deeply involved in this complicated project. In order to succeed, we strengthened our Teams in RA/ QA and R&D and increased the company’s competence within these departments.

A few days ago, the process of transition to TÜV Nord and the renewal of certificates was successfully accomplished. All relevant SIS Medical products have now TÜV Nord MDD certificates for at least two years or longer which gives us the room to maneuver in our MDR uplift strategy.

This is a meaningful team-achievement which involved not only all our employees but also our distribution partners and clinical customers, who kept their trust and confidence into our company during the 2 months of supply interruption with the SIS Medical products.

2021 is a year in which we see not only challenges but also several opportunities. Along with the MDR uplift we are working on the filing for the registration with the US FDA and with Chinese NMPA. The FDA clearance and the MDR readiness are expected at the beginning of 2022. The Chinese registration will be filed in the first half of 2022.

These projects will significantly increase our geographical footprint and move the SIS Medical AG on the next level in the company history.

We, as the SIS Medical team, are looking forward to the upcoming face-to-face meetings with our customers on conventions and during hospital visits. It is about time to carefully reset the social activities and travel. The upcoming release of pandemic-related restrictions gives us additional motivation.

We thank everybody who stayed with us during these difficult times and we are looking forward to seeing you soon.

Wish the best wishes

Sergej Kammerzell, CEO

Willi Zwahlen, Sr. Vice President Sales and Board Member

Become and remain OP(E)N minded!

After more than 10 years available on the market and with more than 60'000 calcified coronary arteries successfully treated (approx. 20'000 within the last 12 months), which means: optimal lesion preparation prior stenting achieved, residual stenosis eliminated, so called undilatable lesions dilated, ISR successfully treated and more; the OPN NC Super High Pressure Balloon has widely proven it`s great effectiveness and safety and it`s large potential for the future for the treatment of complex and calcified lesions. The increasing demand for this product is showing that the convinced community of users is growing fast.

Still, the OPN NC is mainly spelled like O – P – N , this is not the idea! Simply spell it OP(E)N because this is all the meaning in short! " TO OPEN " narrowed arteries to achieve best lesion preparation or postdilatation of suboptimal implanted stents with residual stenosis, treat successfully ISR and more. In order to provide your patients with the best lumen and blood flow for a potentially long lasting and event free result. A very rewarding achievement for your patients, yourself as the responsible operator and for us as developer, producer and marketer of this extraordinary device.

Therefore: "Become and remain OP(E)N minded!"

Thank you for your great work and support!

Yours sincerely

Willi Zwahlen
CEO

With full motivation into 2019

The year 2018 provided quite a number of good news, with OPN NC approved in India and 3 new balloon catheter versions rolled out to the market. All of them have shown very good initial success. The OPN NC is gaining acceptance in India and lots of success stories have already been reported. 

The 3 new balloon catheter lines have already shown excellent performance in the countries where they have already been approved. 

The success story will continue with the timely completion of challenging milestones set for this year, as they are, out of many others: 

  • adding on several new markets by regulatory approval on the way to the global presence of our products
  • the ISAR-Calc Study completion
  • the role-out of next generation products, as for example, the upgrated OPN NC Super High Pressure Balloon with new hypo tube and integrated hub, which will be presented at next PCR in Paris, in May 2019

In order to achieve these goals we are continuously offering exciting jobs and searching for talented and highly motivated professionals, willing to join our team. Take your time and have a look at our website: www.sis-medical.com/company/career

We are looking forward to an exciting year!

Yours sincerely

Willi Zwahlen
CEO

CE – Certification for 3 new high tech PTCA Balloon Catheter families

Breaking News!

Frauenfeld, July 17th 2018

We are proud to announce today the CE – Certification of 3 new high tech and high performance PTCA Balloon Catheter families!

  • The EasyT - High Performance Low Profile High Pressure Balloon for Pre- and Postdilation
  • The NIC 1.1 hydro - for total and subtotal occlusions
  • The NIC Nano hydro - the ultimate CTO Balloon with lowest crossing profile, hydrophilic coating, highest pressure resistance and lowest compliance.
    SIMPLY THE BEST IN CLASS!

OPN NC receives approval in India

SIS Medical Super High Pressure Balloon OPN NC receives approval in India! A big step in the history and development of SIS Medical on the way to become a global company.

Frauenfeld, June 15th 2018

SIS Medical receives import licence, means approval for marketing of the OPN NC Super High Pressure Balloon as well as for the NIC Nano 0.85 and NIC 1.1 CTO balloons in India!

India is one of the largest and fastest growing markets for our products worldwide and our unique products, specially the OPN NC Super High Pressure Balloon without any competition will have a great introduction in this key market. First feedbacks on the news by Indian Key Opinion Leaders have been very enthusiastic and promising: "We have been waiting for a long time to see this products come to our market, we need it and we will use it." 

Thanks to our Distribution Partner, Translumina Technologies, represented by the Chairman of the Company Mr. Grumit Singh. We are thankful for the help of him and his team for the strong support in order to achieve this goal.

We are looking forward to other great news to report and remain

Willi Zwahlen
CEO 

 

At the beginning of another challenging year

Time is going by fast and we at SIS Medical entered another challenging year, let`s call it: "The year of proof."

Several new product launches are planned and a number of product approvals in major markets are on our screen and target.

I take this opportunity to welcome our new Distribution Partner for Poland, the company ProCardio and it`s entire Team. Having already a outstanding portfolio of high quality products, ProCardia has already accomplished a brand with a excellent reputation, being very professional and highly reliable. "The company to work with in vascular interventions in the polish market." We are very happy to work together and we are sure that this will be a success story for both of the companies.

But not only this, we also would further strengthen our reputation in being a very innovative high quality company, providing our customers around the globe with first class products and proof that we are: " The reliable partner to work with, delivering what we announce! "

Looking forward to inform you about further good news.

Yours sincerely

Willi Zwahlen

CEO

 

EuroPCR 2018

GREAT NEWS TO TALK ABOUT! 

The EuroPCR 2018 from May 22nd to May 25th in Paris, will be another milestone in the history of SIS Medical.

  1. Having the company represented by the implementation of a new, attractive and modern booth concept of 3 times the m2 size of the years before.
  2. SIS Medical is announcing the launch of 3 new PTCA balloon families which will become available to our customers soon after the congress.

For more information you are kindly invited to visit us at our booth M10 on level 2. Get all details about the new products and take a little break from the intensive program of sessions and life cases.

Welcoming you at PCR 2018 in Paris, we remain

Yours sincerely

Willi Zwahlen
CEO

The OPN NC Super High Pressure Balloon (RBP 35bar) success story is continuing

Initially recommended and used for the treatment of so called ''undilatable coronary lesions'' after all other NC balloons have failed (very high pressure dilation for undilatable coronary lesions, Gioel Gabriel Secco) and for post dilatation of stent in highly calcified lesions, it has became an important tool in the armamentarium of the Interventional Cardiologist.

In combination with rotablation in highly calcified lesions (see video sequences below, courtesy of Kambis Mashayekhi, MD, Bad Krotzingen).

Case 1: CTO of LCX

Rotablator wire: 1.5mm burr

Wire exchange to ConfiancaPro and stenting of LCX

 

DES implantation after rotablation:

Stent not fully expanded

Post dilatation with OPN NC at 50atm

Final result

 

 

Case 2:

Watch Video: Rotablation used in combination with OPN NC

Note: SIS Medical does not recommend to inflate the OPN NC higher then 35 RBP. The use of extended pressures remains in responsibility of each operator.