A Digital Publication for the Practicing Medical Specialist, Industry Executive & Investor

No Carolina / New York

Vectorious Medical Technologies Begins the VECTOR-HF II Study of its Implantable In-Heart Sensor for Left Atrial Pressure-Guided Patient Self-Management of Heart Failure

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 Medical Technologies 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.

Vector Medical Technologies said 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.

Vectorious Medical Technologies Ltd. is a Tel Aviv-based company, founded in 2011. The company’s V-LAP System enables heart failure patients to better control their disease and live fuller, longer lives by remotely monitoring the heart’s Left Atrial Pressure (LAP) to detect fluid accumulation in the earliest stages of the disease, prior to obvious physiological symptoms. A patient app further empowers the patient to self-titrate medication in real-time based on data extracted from the heart.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

Dr. Michael Newman, Indaptus’ Founder, Chief Scientific Officer, and lead author, commented, “The new data are consistent with our preclinical animal tumor model studies and provide evidence for our hypothesis that patented Decoy bacteria can activate a wide range of innate and adaptive human immune cells involved in fighting tumors.  This aligns with what we’ve observed in our ongoing Phase 1 clinical trial of Decoy20 – broad immune activation, as evidenced by transiently increased levels of many key cytokines and chemokines following single dose administration. These findings bolster our confidence in Decoy20's potential as a multifaceted immunotherapy.”
To further understand the impact of platforms like TikTok on nutrition trends, MyFitnessPal partnered with Dublin City University on a research and experimental study that examined diet and nutrition content on TikTok. The study analyzed over 67,000 videos using Artificial Intelligence to compare them against public health and nutrition guidelines
Leveraging the power of Apple Vision Pro to seamlessly blend digital content with the physical world Osso Health brings the operating experience to life via detailed, clinically accurate workflows of common procedures.
“We are excited to present the first look at the safety and clinical activity of ELVN-001, which we believe supports the potential for ELVN-001 to address the limitations of the available active-site TKIs,” said Helen Collins, M.D., Chief Medical Officer of Enliven. “Across a wide dose range, ELVN-001 demonstrated activity in a heavily pre-treated patient population that includes post-asciminib patients, with a preliminary safety profile consistent with its highly selective design. Not only did all evaluable patients have improved or stable BCR::ABL1 transcript levels, but, importantly, 89% of all patients enrolled remain on study. We believe the initial data demonstrate the potential clinical utility of ELVN-001 for all types of patients, including those that are earlier in the treatment paradigm.”
The partnership is with Health-HavenRx ™, an online pharmacy platform. This partnership enables a new, convenient channel for patients to access POGO Automatic by using their health insurance on Intuity Medical’s e-commerce website at www.GoodtoPogo.com.

By using this website you agree to accept Medical Device News Magazine Privacy Policy