Successful First In-Human Implantation of the V-LAPTM Pressure Sensor Completed
Tel-Aviv, Israel (4 February, 2019) – Vectorious Medical Technologies, a medical device company enabling optimal management for heart failure patients, today announced the initiation of the VECTOR-HF First-in-Human (FIH) clinical trial, and the successful first ‘in-human’ implantation of the V-LAPTM monitoring device.
The VECTOR-HF First-in-Human (FIH) trial will enroll up to 30 patients at six European sites across Germany, Israel, Italy and the UK. It is a prospective, multicenter, single-arm, clinical trial designed to assess the safety and performance of the V-LAP system in preparation for receiving the CE Mark.
Vectorious’ V-LAP sensory device is the world’s first digital, wireless, battery-less device that is able to communicate from deep within the body using high-resolution waveform morphology. Since the pressure of the heart’s left atrium is the earliest and most accurate real-time indication of heart failure exacerbation, the actionable feedback provided by the V-LAP will enable a significant improvement in ongoing management of heart failure patients. Once patients are implanted with the V-LAP, they will be able to measure left atrial pressure (LAP) daily at home via an easy, non-invasive method using a small, portable external unit.
Implantation of the device in this first “In-Human” trial was completed in just six minutes. It was fixated within the patient’s interatrial septum of the heart using a standard minimally-invasive percutaneous procedure under fluoroscopy and echocardiographic guidance, with the application of local anesthesia
Left atrial pressure has been scientifically established as the most specific physiological indication for heart failure exacerbation. Approximately 90% of patients admitted to the hospital for heart failure have pulmonary congestion related to elevated left atrial filling pressure (LAP) . The increase of LAP is the earliest sign of impending heart failure exacerbation – long before clinical symptoms occur.
“The increase of LAP is the most specific and earliest sign of impending heart failure exacerbation – long before clinical symptoms occur. V-LAP’s unmet clinical need has been evident for years, and the cardiology profession will benefit greatly from the availability of technology that can provide this valuable indication non-invasively on a daily basis.” said William T. Abraham, professor of Internal Medicine, Physiology, and Cell Biology, Ohio, USA.
“This technology will really change the way we manage patients with severe heart failure,” said Prof. Horst Sievert, the director of the CardioVascular Center Frankfurt, Germany, who performed the first implantation. “This is the first device that specifically enables us to monitor pressure within the left side of the heart - and because of its cloud-based system, we can access patient data on-demand, monitoring the atrial pressure and managing dosages, medications and overall quality of life consistently and remotely.”
“Implanting our first patient in the VECTOR-HF trial is a significant achievement that moves us closer to our goal of enabling optimal management for heart failure patients,” said Oren Goldshtein, Chief Executive Officer and co-Founder of Vectorious. “This is very advanced technology that we hope will improve the future of chronic cardiac disease treatment.”
The V-LAP system was designed and developed by Vectorious Medical Technology to provide better treatment for heart failure. It is a simple, minimally-invasive device implanted into the left atrial to monitor pressure, enabling easy-to-access data through a Cloud-based system. The Vectorious system intend to increase CHF patient quality of life and reduces readmission rates. With its user-friendly external home-unit, physicians can get daily 'push button' readings of patient hemodynamic pressure to provide early, accurate physiological indication of cardiac decompensation. This not only helps physicians save lives and cut healthcare and hospital costs, but also enables patients to enjoy ongoing, personalised care with an improved quality of life.
About Vectorious Medical Technologies
Vectorious targets optimal HF treatment based on its V-LAP sensory implant. The V-LAPTM Implant Pressure Sensor is the world’s first digital, wireless, battery-less device that is able to communicate from deep within the body. It provides actionable feedback based on high resolution waveform morphology from the heart’s left atrium - the earliest and most accurate indication for heart failure exacerbation. The left atrial pressure (LAP) is measured at home by the patient using an external unit on a daily basis and is monitored remotely by the physician using its cloud-based technology.
Vectorious Medical Technologies is based in Tel Aviv, Israel and led by Co-Founder and CEO, Oren Goldshtein. The company is backed by leading investors including Fresenius Medical Care, Broadview Ventures, and GoCapital. For more information, please visit http://vectoriousmedtech.com.