First-in-Human Implantation of Saturn Transcatheter Mitral Valve Reported Successful

HRS Scientific Sessions: Boston Scientific LBCT

During the Heart Rhythm Scientific Sessions this week, Boston Scientific announced positive LBCT data underscoring the safety and efficacy of multi-site pacing (MSP) over conventional cardiac resynchronization therapy (CRT), as well as poster presentations on real-world use of the WATCHMAN Left Atrial Appendage Closure (LAAC) device and next-generation WATCHMAN FLX LAAC device as alternatives to oral anticoagulation therapy for stroke risk reduction in patients with non-valvular atrial fibrillation.

What are the Most Commonly Performed Surgeries?

Whether you are trying to learn more about a surgery you are planning to have or find out what the most common procedures are, this list is here for you. Read more.

B2B Training: What’s the Most Effective Way of Learning?

B2B training, which is short for business-to-business training, is a popular and convenient type of training that enables entire companies to train their teams...

September 24, 2020

The first-in-Human implantation of InnovHeart’s proprietary Saturn Transcatheter Mitral Valve was successful along with excellent results at the 30-day follow-up for the patient, a 72-year-old male suffering from severe Functional Mitral Regurgitation. The Trans-Apical TMVR procedure was performed as part of an on-going European clinical trial on August 19, 2020 at Santaros Klinikos University Hospital in Vilnius, Lithuania with the Heart Team of Kęstutis Ručinskas, MD, Audrius Aidietis MD, Vilius Janušauskas, MD, and Valdas Bilkis, MD supported by Paolo Denti, MD and Stefano Stella, MD.

“We are grateful to have had the opportunity to work with Dr. Denti, Dr. Stella, and the InnovHeart team in order to provide a novel treatment option for this high-risk patient,” said Dr.Kęstutis Ručinskas, Primary Investigator and Head of Cardiac Surgery at Santaros Klinikos. “Although it was the first clinical use of the Saturn valve, the procedure was straight-forward, and the valve was implanted successfully with excellent function.”

“The Saturn implant is unique in the way it combines a transcatheter bioprosthetic valve with an annular structure to remodel the native annulus and seal the perimeter of the implant, thus eliminating mitral regurgitation and restoring optimal valve function,” added Dr. Audrius Aidietis, Head of Interventional Cardiology at Santaros Klinikos. “After 30 days, the patient has already experienced a noticeable reduction in symptoms, with improvements in six-minute walk test, KCCQ Quality of Life survey and a reduction from NYHA III to NYHA II.  In addition, the valve continues to exhibit outstanding hemodynamic performance with no MR and no outflow tract obstruction.”

“Having worked with Giovanni Righini and the InnovHeart team throughout the pre-clinical development, I am pleased to have reached this important milestone together in the interest of the many patients suffering from severe MR,” said Paolo Denti, MD, InnovHeart Consultant and Cardiac Surgeon at San Raffaele University Hospital in Milan, Italy. “This was a multidisciplinary success. Every step of the procedure was methodical and controlled with standard echo and fluoro imaging. More importantly, the patient was stable throughout the procedure, despite severe ventricular dysfunction. It did not feel like a first human implant, and the short duration of the procedure speaks for itself. I am confident that the Saturn TMVR system will become a valuable new therapy with fewer exclusion criteria than other technologies, with the potential to treat a wider range of patients.”

“The initial clinical experience has been very encouraging and confirms the unique benefits the Saturn TMVR system can offer in terms of annular support, LVOT preservation, sealing capability and procedural predictability. We look forward to providing similar comprehensive treatment for many other patients with MR in the future. Continued enrollment in our European Trans-Apical Pilot Study will provide valuable follow-up data and support for the on-going development of our Trans-Septal delivery system, which utilizes the same Saturn implant,” added Brent Ratz, InnovHeart Chief Executive Officer.

*The Saturn Transcatheter Mitral Valve system is limited to investigational use and is not commercially available.



Mediclinic Appoints 2 New Independent Non-Executive Directors

Natalia Barsegiyan and Zarina Bassa will bring significant and diverse skills and experience, complementing those of existing Board members. I am confident they will both be great additions to our Board of Directors.”

Asensus Surgical Appoints Two New Board Members

Asensus Surgical, Inc. (NYSE American: ASXC), a medical device company that is digitizing the interface between the surgeon and the patient to pioneer a new era of Performance-Guided Surgery™, today announced the expansion of its Board of Directors, appointing...

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.