Vectorious' June 2019 Newsletter View in your browser 
Dear colleague,

Recently, Vectorious took part in two major cardiovascular conferences: EuroPCR (Paris) and the ESC Heart Failure Conference (Athens), where the V-LAP system took central stages and was presented in various sessions. It was clear that the industry is enthusiastic about the potential of Vectorious' technology and interested in hearing about the VECTOR-HF study. 

This led us to create the VECTOR-HF newsletter - a place where you will be able to stay up to date with all the latest developments in the clinical, medical and R&D fronts related to the V-LAP. I hope you enjoy the read and please let us know if you have any questions or comments.

From all of us at Vectorious, good luck with patient recruitment, looking forward to a future of ambulatory care for patients with heart failure!

Oren Goldshtein, CEO
  Latest Updates
  1. Vectorious successfully implanted the V-LAP sensory device in a 3rd patient in Policlinico, Gemelli University Hospital in Rome, one of the largest private hospitals in Europe. The procedure was led by Professor Filippo Crea. 
  2. All three minimally-invasive procedures so far, were successful, with no complications. The sensor deployment took several minutes. The study’s primary and secondary endpoints have been met for the first two patients. An RHC demonstrated correlation between LAP and PCWP (gold standard) during implantation and at 3-month follow up. 
  3. Vectorious has activated a new site: Shaare Zedek Medical Center in Jerusalem. We’re working with principal investigator Dr. David Meerkin, who is supervising this study. 
  4. The first CEC-DSMB (Clinical Events Committee – Data Safety Monitoring Board) committee will gather during Q3 2019, and we are looking forward to hearing their findings.
  Patient Enrollment Status  

We have decided to take the following steps in order to boost patient enrollment:

  1. Generate a treatment protocol. Although the goal of our study is to demonstrate feasibility (safety and accuracy), the physicians involved still expect us to provide medication adjustment guidelines based on the LAP readings. We have recently created a basic guideline protocol based on the experience of the CHAMPION and the LAPTOP-HF trials.
  2. We have opened the eligibility criteria in the UK to include patients with permanent atrial fibrillation, who represent more than 20% of our target population. We intend to act in similar fashion in Italy and in Germany.
  First In Human Studies Insights

Recently we have revealed the LAP readings we received from the first 2 studies conducted in Italy (Professor Carlo Di Mario) and Germany (Professor Horst Sievert). We were excited to see clean and accurate readings that have already led to meaningful insights for the medical teams. So far, we have more than 100 measurements for each patient. You can find below an example of the trend of pressure over time:

  Case Study: Detecting Sleep Apnea

We already have an interesting case study, from the first implementation in Germany, where after we analyzed the readings, we detected a suspected co-morbidity:

The second half of the tracing looks like exaggerated respiratory variation, often seen in LAP tracings during episodes of obstructive sleep apnea. The patient was sent for a sleep apnea test, which confirmed severe sleep apnea (AHI = 41). Thereafter the patient was referred for a proper treatment.
Recruitment Tips

As you all know we have created 35 eligibility criteria. In order to simplify the screening process, once the patient  fulfills the following 7 criteria it’s likely he is suitable for the study:
  1. NYHA Class III
  2. eGFR is over 30 mL/min/1.73 m2
  3. Systolic or diastolic heart failure (LVEF>15%)
  4. Prior HF hospitalization in the last 12 months or elevated BNP/ NTPro-BNP
  5. PASP is lower than 70 mmHg
  6. No permanent atrial fibrillation
  7. No severe valvular dysfunction
Industry Updates

CardioMEMS Sensor Reliable, Safe; Hospitalizations Reduced by More Than Half
American College of Cardiology, March 17th
CardioMEMS HF sensor demonstrated a 58% reduction in hospitalizations
Read More

Late-Breaking Data on Device Therapy for Improved Heart Failure Management
Heart Failure Congress News, May 28th
Interesting  review of the presentation by Professor William Abraham (Ohio State University, USA), sharing early findings from the VECTOR-HF study
Read More

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