BioVentrix Receives CE Marking Certification for Revivent TC

BioVentrix Inc., an emerging medical device company dedicated to the minimally invasive treatment of heart failure (HF), has received certification for CE Mark approval for its Revivent TC TransCatheter Ventricular Enhancement System. Following a myocardial infarction or heart attack, the Revivent TC System implants proprietary micro-anchor pairs to exclude scarred myocardium from the healthy tissue of the left ventricle (LV). The restoration of the LV to a more optimal volume and conical shape has proven to enhance cardiac performance and significantly improve a patient’s quality of life.¹
 
“The certification for CE marking is not only an important milestone for the company, but also for those who treat heart failure,” said Kenneth Miller, president and CEO of BioVentrix. “More importantly, it transforms the spectrum of treatment by offering a minimally invasive therapeutic solution for the previously ignored ventricle. By making this treatment available, we are giving physicians an important additional resource that they can utilize in conjunction with existing valvular and vascular therapies, making Guideline-Directed Medical Therapy (GDMT) even more effective. Moreover, it provides access to efficacious and tolerable therapy to many frail patients who previously would have no options. More than 100,000 patients will become eligible each year for this device implant.”

At two-year follow-up, patients have made remarkable improvements in their Quality of Life by 38 percent. Additionally, the clinical benefit has been proven to extend life for patients with a significant reduction of LV end-systolic volume index (31 percent) and improvement of LV ejection fraction (23 percent)². Left ventricular volume reduction is especially critical for the survival of a patient as other studies have shown that significant LV volume reduction can directly prolong a patient’s life¹. The Revivent TC System is the only interventional therapy that can consistently achieve this survival benefit in heart failure patients.
 
“Heart failure remains an epidemic worldwide and the CE marking certification validates the need for a novel therapy for heart failure patients suffering from left ventricular dysfunction,” added Dr. Lon Annest, chief medical officer of BioVentrix. “There is no doubt that LV volume reduction is an important therapy as it directly impacts the parameters that determine prognosis and survival, such as LV volume and ejection fraction. The impact of the Revivent TC System is achieved by transcatheter access to exclude the ischemic portion of the left ventricle from the healthy tissue. This empowers heart teams in Europe, who currently have a backlog of patients, and soon, in the US, to ensure optimal clinical outcomes by minimizing the risk compared to conventional surgery.”
 
Placement of the Revivent TC System via the LIVE procedure obviates the need for more invasive surgery. Instead, small titanium anchors are placed along the outer surface of the heart and along one of the interior walls via a closed-chest, endovascular approach. The anchors are then pulled toward one another, effectively excluding the scarred and non-functioning heart wall. Ventricular volume is immediately reduced as a result of the exclusion, by as much as 30-40 percent.³
 
The LIVE procedure is based upon a well-defined law of physics called the law of Laplace, which describes the relationship between the radius and pressure of the LV, and its resulting wall tension. Increased wall tension is the underlying cause of LV enlargement, worsening heart failure symptoms and ultimately patient death. Reducing wall tension is key to preventing further LV enlargement and treats the progression of the disease. The Revivent TC System, placed via the LIVE procedure, is uniquely designed to directly reduce the LV radius, which in turn decreases wall tension and interrupts the ongoing, destructive process of heart failure.

References:
1. Michler R et al. Insights from the STICH trial: Change in left ventricular size after coronary artery bypass grafting with and without surgical ventricular reconstruction. J of Thoracic and Cardiovascular Surgery. 29 October 2012 (10.1016/j.jtcvs.2012.09.007).
2. Data available on file.
3. Wechsler, A. et al., Clinical benefits twelve months after less invasive ventricular restoration operations without ventriculotomy. Annual meeting of the European Society of Cardio-Thoracic Surgery, 07 Oct. 2013, Vienna, Austria.