For the first time, heart failure patients can have full visibility of their hearts’ LA pressure and self-adjust their medication to stop further deterioration and avoid hospitalizations
Vectorious Medical Technologies Ltd., today announced that it has enrolled the first six patients in the VECTOR-HF II Study, which will evaluate the V-LAP System’s novel approach of patient self-management for detecting and managing heart failure (HF) early, before it further damages the heart.
The study includes New York Heart Association (NYHA) class II and III HF patients who will be implanted with the V-LAP in-heart implantable sensor. Direct pressure readings from the left atrium (LA), captured by the V-LAP sensor, will be visible to both physicians and patients using dedicated apps for the patient and for the clinic.
Remote access to pressure data generated from the LA, the most specific and comprehensive indication for fluid accumulation, enables physicians to provide early, personalized and more accurate treatment to HF patients while taking into account other comorbidities inside and outside the heart.
The V-LAP System also allows HF patients, for the first time, to take an active role in managing their disease. Using the V-LAP System, they will have an opportunity to obtain real-time understanding of the correlation between their daily medication routine and activities, and their heart’s LA pressure. When LA pressure is out of the optimal range, patients are guided to adjust diuretics based on the predefined treatment plan. If the LA pressure is in suboptimal ranges, the medical team is notified and can provide additional instructions to prevent further deterioration.
“The V-LAP System is the first wireless digital platform that enables chronic HF patients to manage their disease by titrating the dosing of their medication directly in response to accurate, very early detection of fluid accumulation,” said Vectorious CEO and co-founder Eyal Orion, MD. “The successful completion of the VECTOR-HF I study and the launch of the VECTOR-HF II study are exciting milestones for Vectorious and for patients suffering from severe, chronic HF, and the culmination of more than a decade of development work required to enable placing a digital sensor directly in the heart. We strongly believe that the unique data from the heart’s LA, coupled with our technological platform, which enables millions of HF patients to take ownership of their disease, is the right and only way to transform treatment paradigm.”
Although the importance of assessing pressure buildup in the heart’s LA during acute HF has been clinically validated for decades in the ICU setting, obtaining this information daily and remotely in chronic HF patients has not been feasible. Vectorious’ V-LAP sensor is the first wireless digital implant that is clinically shown to provide long-term accurate and reliable LA pressure readings from deep inside the heart, without the need for invasive calibration. For this reason, the FDA awarded a breakthrough designation to the V-LAP System in 2020.
VECTOR-HF II is a prospective, multi-center, single-arm study that was launched in Europe in January 2022, with plans to enroll 20 patients. In November 2021, the company completed its successful VECTOR-HF I study, which included 30 patients. Lessons learned from VECTOR-HF II will be incorporated into VECTOR-HF III, a larger pivotal study which is scheduled to begin in the US in 2023 with the goal of achieving FDA approval.
The results of the VECTOR-HF I study will be presented at the prestigious Late-Breaking Trials session during the European Society of Cardiology Heart Failure 2022 conference in Madrid, Spain.
Source: Company Press Release