Background Image

News

Press Published

News Releases

CMS Agrees With VisCardia on the Value of Synchronized Diaphragmatic Stimulation

VisCardia Receives US FDA IDE Approval to Start the RECOVER HF Clinical Study

VisCardia Selected in Top 50 Medical Device Start-Ups by MedTech Innovator to Participate in a Global Flagship Showcase and Accelerator Program (.pdf)

VisCardia Announces Issuance of American Medical Association CPT® Category III Codes
for Synchronized Diaphragmatic Stimulation (SDS®)

VisCardia Announces Its Novel Heart Failure Therapy Receives Breakthrough
Device Designation From the FDA

VisCardia Announces Completion of Its VisONE Heart Failure Pilot Study

VisCardia Announces Completion of Enrollment and Three Month
Follow-Up Visits for Its VisONE® Heart Failure Pilot Study

VisCardia Announces First Implant of the VisONE® System for Treating Heart Failure

VisCardia Completes $12.5 Million Series B Financing and Assets Transfer to Develop Proprietary Therapeutic Heart Failure Application and Appoints Michael Mirro M.D. as Director of Medical Affairs

Publications

2025

  1. Fudim M, Becker G, Shaburishvili T, Chabrishvili D, Zirakashvili, Oniani B, Shaishmelashvili G, Mirro M, Goldberg L. RECOVER-HF Pilot Study : Synchronized Diaphragmatic Stimulation for HFrEF Therapy. (presented at the THT conference, 2025, Boston, Massachusetts).


2024

  1. Goldberg L, Mirro M, Becker G, Shaburishvili T, Fudim M. Synchronized Diaphragmatic Stimulation for the Treatment of HFrEF – A Review. Submitted to Heart Failure Reviews.

  2. Fudim M, Becker G, Shaburishvili T, Chabrishvili D, Zirakashvili, Oniani B, Shaishmelashvili G, Mirro M, Goldberg L. RECOVER-HF Pilot Study : Synchronized Diaphragmatic Stimulation for HFrEF Therapy. (presented at the CSI-D conference, 2024, Frankfurt, Germany).


2023

  1. Achanta S, Arand P, Mirro M, Fudim M. Synchronized Diaphragmatic Stimulation Effects on Cardiovascular Function : Advanced Instrumentation Heart Failure Animal Model. (presented at the THT conference, 2023, Boston, Massachusetts).

  2. Becker G, Shaburishvili T, Chiabrishvili D, Oniani B, Shaishmelashvili G, Fudim M, Mirro M, Goldberg LR. Synchronized Diaphragmatic Stimulation as a Potential Outpatient Implant Procedure for HFrEF Therapy. J Cardiac Failure. 2024, 30(1) : 139. (presented at the HFSA conference, 2023, Cleveland, Ohio). https://doi.org/10.1016/j.cardfail.2023.10.057.

  3. 3. Becker G, Shaburishvili T, Chiabrishvili D, Oniani B, Shaishmelashvili G, Fudim M, Mirro M, Goldberg LR. Synchronized Diaphragmatic Stimulation : Potential Outpatient Implant Procedure for HFrEF Therapy. (presented at the CSI-D conference, 2023, Frankfurt, Germany).


2022

  1. Salah HM, Goldberg LR, Molinger J, Felker GM, Applefeld W, Rassaf T, Tedford RJ, Mirro M, Cleland JCF, Fudim, M. Diaphragmatic Function in Cardiovascular Disease : JACC Review Topic of the Week. JACC. 2022, 80(17) : 1647-1659. https://doi.org/10.1016/j.jacc.2022.08.760.

  2. Jorbenadze A, Goldberg LR, Shaburishvili T, Zuber M, Mirro M, Fudim M. Synchronized Diaphragmatic Stimulation for Heart Failure with a Reduced Left Ventricular Ejection Fraction using the VisONE System : A First-in-Patient Study with Extended Population. Structural Heart J. 2022, 6(6), 100103, https://doi.org/10.1016/j.shj.2022.100103.

  3. Jorbenadze A, Young R, Shaburishvili T, Demyanchuk V, Buriak R, Todurov B, Rudenko K, Zuber M, Stampfli SF, Tanner FC, Erne P. Mirro M, Fudim M, Goldberg LR, Cleland JGF. Synchronized Diaphragmatic Stimulation for Heart Failure using the VisONE System: A First-in-Patient Study. ESC Heart Failure. 2022, 9:2207-2214. PMID: 35619238, DOI: 10.1002/ehf2.13984.

  4. Jorbenadze A, Shaburishvili N, Fudim M, Mirro M, Shaburishvili T. Synchronized Diaphragmatic Stimulation for Chronic Heart Failure with Reduced Ejection Fraction: Case Report. JACC. 2022, 79 (9 supplement): S2200. (presented at the ACC conference, 2022, Washington D.C.).

  5. Fudim M, Jorbenadze A, Mirro M, Goldberg L. A Multi-center First-in-Human Prospective Study to Evaluate the Safety and Efficacy of Synchronized Diaphragmatic Stimulation for HFrEF: Expanded Population. (presented at the THT conference, 2022, New York, New York).

  6. Goldberg LR, Jorbenadze A, Shaburishvilli T, Mirro MJ, Fudim M, Zuber M, Staempfli SF, Tanner FC, Erne P, Cleland JC. Synchronized Diaphragmatic Stimulation: A Case Report of a Novel Extra-cardiac Intervention for Chronic Heart Failure. ESC Heart Fail. 2022; 9(3): 1677-1681. https://doi.org/10.1002/ehf2.13882.

  7. Fudim M, Mirro M, Goldberg LR. Synchronized Diaphragmatic Stimulation for the Treatment of Symptomatic Heart Failure: A Novel Implantable Therapy Concept. . JACC: Basic to Translational Science. 2022; 7(3): 322-323. https://doi.org/10.1016/j.jacbts.2022.02.012.


2021

  1. Arand P, Bauer P, Cheng J, Harris G, Fudim M. Device-based Activity Assessment in Chronic Heart Failure Patients Undergoing Synchronized Diaphragm Stimulation. J Cardiac Failure. 2022, 28(5): S52. (presented at the HFSA conference, 2021, Denver, Colorado).

  2. Bauer P, Cheng J, Harris G, Arand P, Fudim M, Mirro M. Synchronized Diaphragmatic Stimulation: Device-based Activity in Chronic Heart Failure Patients. (presented at CSI Focus D-HF, 2021, Frankfurt, Germany).


2020

  1. Cleland JGF, Young R, Jorbenadze A, Shaburishvili T, Demyanchuk V, Buriak R, Todurov B, Rudenko K, Zuber M, Staempfli SF, Tanner FC, Erne P, Mirro M, Goldberg L. A First in Human Multi-center, Open Label, Prospective Study to Evaluate Safety, Usability and Performance of the VisONE System for Heart Failure with a Reduced Left Ventricular Ejection Fraction. J Cardiac Failure. 2020, 26(10): S64. (presented at the HFSA conference, 2020, virtual).

  2. Jorbenadze A, Shaburishvili N, Mirro M, Zuber M, Erne P, Shaburishvili T. First-in-Human VisONE Heart Failure Study: Asymptomatic Diaphragmatic Stimulation for Chronic Heart Failure with Reduced Ejection Fraction – Case Report. JACC, Vol 75, Issue 11 Supplement 1, March 2020.

2019

  1. Zuber M, Young R, McConnachie A, Shaburishvili T, Rudenko K, Demyanchuk V, Jorbenadze A, Buriak R, Todurov B, Mirro M, Nikitin N, Erne P, Cleland J. First in Human VisONE Heart Failure Study: Asymptomatic Diaphragmatic Stimulation for Chronic Heart Failure : One Month Results. J Cardiac Failure. 2019, 25(8): S183. (presented at the HFSA conference, 2019, Philadelphia, Pennsylvania).

  2. Zuber M, Young R, Shaburishvili T, Rudenko K, Demyanchuk V, Jorbenadze A, Buriak R, Todurov B, Mirro M, Nikitin N, Erne P, McConnachie A , Cleland J. First-in-Human VisONE Heart Failure Study Implant Experience and Study Design: Asymptomatic Diaphragmatic Stimulation for Chronic Heart Failure. Eur J of HF. 2019; 21 (suppl. S1): P523-524. (presented at the ESC HF conference, 2019, Athens, Greece).

2018

  1. Saccocci M, Luciani M, Cesarovic N, Lipiski M, Kuwata S, Guidotti A, Regar E, Zuber M, Maisano F. Diaphragmatic Stimulation Effects on Cardiovascular Function – a New Acute Porcine Heart Failure Model. Cardiovascular Medicine. 2018; 21(05): P32. (presented at the Swiss Society of Cardiology conference 2018, Basel, Switzerland).

2017

  1. Beeler R, Schoenenberger A, Zuber M, Bauer P, Erne S, Schlaepfer R, Erne P. Sustained Improvements to Ventricular Function due to Asymptomatic Diaphragmatic Function. J Cardiac Failure. 2017; 23(8):S120. (presented at HFSA 2017, Dallas, Texas)

  2. Bauer P, Snell J, Wheeler T, Chinchoy E, Mirro M. Animal Instrumentation Model of Diaphragmatic Stimulation Effects on Cardiovascular Function. J Cardiac Failure. 2017; 23(8):S120. (presented at HFSA 2017, Dallas, Texas).

  3. Beeler R, Schoenenberger A, Zuber M, Bauer P, Erne S, Schlaepfer R, Erne P. Stability of Asymptomatic Diaphragmatic Stimulation Thresholds after 1 Year : Results of the Epiphrenic II Pilot. J Cardiac Failure. 2017; 23(8):S120. (presented at HFSA 2017, Dallas, Texas).

  4. Beeler R, Schoenenberger A, Zuber M, Bauer P, Bergner M, Erne S, Schlaepfer R, Erne P. Sustained improvements to ventricular function due to asymptomatic diaphragmatic function. EJH 2017; 38 (suppl 1), ehx504.P3374. (presented at ESC 2017, Barcelona, Spain).

2014
  1. Beeler R, Schoenenberger AW, Bauer P, Kobza R, Bergner M, Mueller X, Schlaepfer R, Zuber M, Erne S, Erne P. Improvement of Cardiac Function with Device-based Diaphragmatic Stimulation in Chronic Heart Failure Patients. Eur J Heart Failure. 2014; 16(3): 342-9.

2010
  1. Zuber M, Roos M, Kobza, R, Toggweiler S, Meier R, Erne P. Detection and Hemodynamic Significance of Cardiac Pacemaker-Induced Phrenic Nerve Stimulation. Congestive Heart Failure. 2010; 16(4):147-152.

2009
  1. Roos M, Kobza R, Jamshidi P, Bauer P, Resink T, Schlaepfer R, Stulz P, Zuber M, Erne P. Improved Cardiac Performance Through Pacing-induced Diaphragmatic Stimulation: A Novel Electrophysiological Approach in Heart Failure Management?. Europace. 2009; 11:191-199.

2007
  1. Toggweiler S, Kobza R, Roos M, Erne P. Visualizing Pacemaker-Induced Phrenic Nerve Stimulation with Acoustic Cardiography. Pacing and Clinical Electrophysiology. 2007; Jun; Vol. 30:806.