BioVentrix Granted CE Mark Extension for Revivent TC System

BioVentrix Inc., developer of the first transcatheter device for left ventricular remodeling after a heart attack, has been granted an extension of its CE Mark for the Revivent TC Transcatheter Ventricular Enhancement System for heart failure to May 2024.
 
“The extension of our CE Mark is not only an important milestone for the company, but also validates the need for a novel therapy for patients with left ventricular dysfunction who are among the estimated 10 million people in the European Union suffering from heart failure,” said Kenneth Miller, president and CEO of BioVentrix. “It ensures that physicians will continue to have an important, less invasive therapeutic option for these patients.”
 
The CE Mark is issued by the European Commission and allows the device to be marketed throughout EU member nations. BioVentrix received its initial CE Mark in 2016.
 
Less Invasive Ventricular Enhancement, or LIVE Therapy, uses the Revivent TC System to exclude scar tissue on the left ventricle that has occurred from a heart attack so the healthy portion of the heart can operate more efficiently. Micro-anchors are implanted and designed to remodel the heart to a more normal shape and size and reduce wall stress, which has been shown to improve blood flow throughout the body.¹
 
Percutaneous coronary intervention (PCI), which implants a stent, is considered the standard of care for restoring blood flow to the heart after a heart attack. However, 50 percent of patients treated with PCI still develop large LV scars,² which cause the heart to dilate. Enlarged LVs are associated with more severe heart failure symptoms, higher mortality and more frequent re-hospitalization.^3,4,5 Positive remodeling of the heart has been shown to improve LV function and heart failure symptoms.^6,7 The only currently available option is surgical ventricular remodeling, which is highly invasive.
 
The Revivent TC System has received the CE Mark and is approved for sale in Europe. It is considered investigational and is not approved for sale in the United States.

A study recently published in the European Journal of Heart Failure showed significant and sustained improvement in heart function, symptom relief and quality of life using BioVentrix’s Revivent TC System. The prospective, multicenter, single-arm study of 89 patients at 22 centers in 12 countries in the European Union was designed to evaluate the efficacy and safety of the Revivent TC System for scar exclusion in the heart, volume reduction, and reshaping of the LV in selected patients with ischemic cardiomyopathy (enlarged and weakened left ventricle with reduced capacity to pump blood after a heart attack). Of the 86 patients successfully treated with the system, 51 patients received delivery via a sternotomy and 35 were treated using a less invasive, hybrid approach without sternotomy.  None of the patients treated in this trial required cardiopulmonary bypass to implant the device.

The study showed the following patient outcomes at 12 months:

• One hundred percent of patients demonstrated significant and sustained reduction in LV volumes. Twenty-seven percent reduction in LVESVI (74 ± 28 ml/m²BSA vs. 54 ± 23 ml/m²BSA, P<0.001); twenty-four percent reduction in LVEDVI (106 ± 33 ml/m²BSA v.s 80 ± 26 ml/m²BSA, P<0.0001)
• Sixteen percent improvement in LVEF (29 ± 8 percent vs. 34 ± 9 percent, P<0.005)
• A 90.6 percent survival rate
• Twenty-seven percent improvement in New York Heart Association (NYHA) functional class (average class of 2.6 vs. 1.9) – 59 percent of subjects were NYHA class III at baseline; at one year, 79.4 percent were class I or II
• Thirty-six percent improvement in quality of life as measured by the Minnesota Living with Heart Failure questionnaire (MLHF) (41 vs. 27 points, p<0.001)
• Eighteen percent improvement in exercise capacity as measured by the Six Minute Walk Test (6MWT – 342 meters vs. 403 meters, p<0.001))
• Fifty percent improvement in average mitral regurgitation (MR) grade in the 68 patients who entered study with measurable functional MR (FMR) of at least grade 1+ at six months (1.12 vs. 0.57) and 24% improvement at 12 months (1.12 vs. 0.86)
• Ninety-seven percent procedural success
• Median length of hospital stay was 14 days; however, subsequent post-market study has seen length of stay decrease substantially as implanters gain more experience

References
¹ Klein P, Ander SD, Wechsler A et al. Less invasive ventricular reconstruction for ischaemic heart failure. Eur J Heart Fail 2019;21(12):1638-1650.
² Stone GW, Selker HP, Thiele H, et al. Relationship between infarct size and outcomes following primary PCI: patient-level analysis from 10 randomized trials. J Am Coll Cardiol 2016;67(14):1674-83.
³ Hamer AW, Takayama M, Abraham KA et al. End-systolic volume and long-term survival after coronary artery bypass graft surgery in patients with impaired left ventricular function. Circulation 1994;90:2899-904.
⁴ Axelrad JE, Pinsino A, Trinh PN et al. Limited usefulness of endoscopic evaluation in patients with continuous flow left ventricular assist devices and gastrointestinal bleeding. J Heart Lung Transplantation : the official publication of the International Society for Heart Transplantation 2018;37:723-732.
⁵ Konstam MA, Kramer DG, Patel AR, Maron MS, Udelson JE. Left ventricular remodeling in heart failure: current concepts in clinical significance and assessment. JACC Cardiovasc Imaging 2011;4(1):98-108.
⁶ Athanasuleas CL, Buckberg GD, Stanley AW et al. Surgical ventricular restoration in the treatment of congestive heart failure due to post-infarction ventricular dilation. J Am Coll Cardiol 2004;44:1439-45.
⁷ Di Donato M, Frigiola A, Benhamouda M, Menicanti L. Safety and efficacy of surgical ventricular restoration in unstable patients with recent anterior myocardial infarction. Circulation 2004;110:II169-73.