Heart Failure Therapy: Innovation

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Part
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Heart Failure Therapy: Innovation

Examples of innovation in treating heart failures are SensiVest, Sacubitril/Valsartan Entresto and CardioMEMS.

SensiVest for heart failure

  • Researchers for Sensible Medical have developed an innovative heart failure treatment device called the SensiVest.
  • The SensiVest can be worn by the patient over their clothes, and the device uses a radar technology "originally developed by the military to scan inside the body and monitor fluid buildup in the lungs."
  • The device saves patients the stress and time of waiting to report their symptoms to a doctor because patients can simply wear the vest. The vest scans the patient for about three minutes and then transmits the information wirelessly to the doctor who can conduct further assessments, recommend dietary changes and intervene with medication.
  • According to a study published in August 2017, "wearing the SensiVest daily for three months decreased hospital readmission by 87 percent."

Sacubitril/valsartan Entresto

  • Sacubitril/Valsartan Entresto is an innovative drug used for the treatment of heart failure.
  • The drug has recently been approved by both the NICE (National Institute Health and Clinical Effectiveness) and the SMC (Scottish Medicine Agency).
  • The drug works in two different ways. First, it boosts the body’s natural resistance against heart failure and second, it blocks the body’s natural system that harms the heart. "It combines two drugs: a new one called Sacubitril and Valsartan, a drug that has been used for some time in heart failure."
  • The mixture of these two drugs has "improved both death rates and hospitalization in heart failure by up to 20% in a clinical trial."
  • Some cons of the drugs include weight gain, vomiting, coughing, and sudden back pain.
  • Some pros include significant improvement in daily functions and energy levels.

CardioMEM

  • CardioMEM is a monitoring system also known as wireless pulmonary artery haemodynamic monitoring.
  • The innovative device works by measuring the pressures in patients' pulmonary artery, "which will rise before a patient notices a deterioration in their heart failure symptoms, e.g. breathlessness or swelling."
  • The device passed through examinations in the USA. A lot of patients who were NYHA III were fitted with the device and then compared with a group of patients who were not. The results over 18 months showed a reduction in hospital admissions of over 37%.
  • The device enables the clinician to better manage heart failure symptoms of patients, and it helps to avoid deterioration and admission into the hospital. Patients also indicated a greater quality of life and reduction in deaths.
  • Some cons of the device include minor anxiety over the procedure and understanding that it is a permanent device.
  • Some pros include fewer CHF-related hospitalizations.

Research strategy

To provide the three examples of innovation in treating heart failure, we started by reviewing industrial articles, market reports, articles, white papers and many more. We have reviewed sources such as CNBC, healthcare weekly and many more. The team has provided three innovation in treating heart failure. These examples were selected based on the impact the treatment has on heart failure patients.
Part
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Part
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Heart Failure Therapy: Innovation 2

The three examples of device innovation in treating heart failure are Optimizer Smart from Impulse Dynamics, V-LAP from Vectorious and the Implantable Peritoneal Ultrafiltration Device (IPUD) from Paragate Medical.

OPTIMIZER SMART

Overview

  • Optimizer Smart was developed by Impulse Dynamics, a German-based company. It was designed to treat patients with chronic heart failure (CHF) who continue to suffer despite adequate medical care.
  • Optimizer smart is an implantable pulse generator that delivers electrical pulses to the patient's heart to reduce symptoms such as irregular or rapid heartbeat, persistent coughing, and fatigue. It also increases the patient's exercise endurance during the complete heart cycle refractory phase, which is a painful experience that occurs shortly after heart contracts.
  • This is to increase the heart's systolic contraction — the blood pressure when the heart contracts in order to boost the efficiency of the heart and the pumping capacity of damaged heart chambers.

Current State

  • Optimizer Smart has been implanted in over 3,500 patients and is available in Europe, China, India, Brazil, and numerous other nations around the world. According to a report published by TCTMD, the German manufacturer has announced that it plans to launch the product in the United States this year (2019).
  • Optimizer Smart was approved as a "breakthrough device" by the United States Food and Drug Administration (FDA) in2015. The Optimizer Smart was then given the CE Mark approval by the FDA in October 2016.

Pros/Cons

  • In 2015, FDA's Circulatory System Devices Panel "voted 12-0 with one abstention in favor of the benefit-to-risk ratio", 12-1 for safety and 11-2 on questions of efficacy.
  • Patients implanted with Optimizer Smart claim that their health improved with an emphasis on their ability to do physical activities.
  • A patient from Hamburg, Germany, Jörg Renelt, claims that for the first month after the implant he did not feel any different and that disappointed him but then his heart performance was up from 30%-60%.

Impact and Disruption

  • In the clinical trials conducted for Optimizer Smart, the study "showed improvements in exercise tolerance as measured by pVO2 (primary endpoint), quality of life on the Minnesota Living With Heart Failure Questionnaire score and 6-minute hall walk test, and NYHA functional status at 24 weeks with CCM compared with optimal medical therapy."
  • It also showed reduced "primary safety composite endpoint of cardiovascular death and heart failure hospitalization".

Future of the Product/Company

  • According to the medical advisor at Impulse Dynamics, Daniel Burkhoff, MD, Ph.D. (Cardiovascular Research Foundation, New York), the company continues to enhance the technology with continued clinical trials that are designed to analyze CCM therapy in heart failure populations.

VECTORIOUS’ V-LAP

Overview

  • Vectorious Medical Technologies, the Israeli med-tech company, has developed the V-LAP sensory implant, which is believed to be the very first left atrial pressure monitoring microcomputer, of its kind, for personalized heart failure treatment.
  • The heart’s left atrium pressure is the most accurate and earliest real-time indicator of heart failures and the company believes that its V-LAP monitoring system positioned in the left atrium will be a significant improvement in the management of heart failure.
  • The V-LAP solution includes a personal, portable belt that allows heart failure patients to independently monitor their status. The belt wirelessly syncs with V-LAP and transmits its data automatically to a system in the cloud where the medical team can access the information, analyze the data, and use it for optimal personalized treatment.

Current State

  • V-LAP is not commercially available.
  • According to the company’s recent announcement, the first implantation of the device has begun this month (October) as part of a first-in-human research study that will enroll over 30 patients from Germany, Italy, Israel, and the United Kingdom.
  • Margaret McDermott from Birmingham was the first British woman to be implanted with V-LAP.
  • Vectorious was named "the best technology and innovation in the field of remote monitoring for chronic heart failure" at the ESC Congress this year (2019).

Pros/Cons

  • Margaret McDermott said that the V-LAP implanted in the left atrium of her heart was a “miracle” and it enhanced the quality of her life ever since she took the surgery in July, this year.

Impact and Disruption

  • Industry experts believe that this technology would be a potential game-changer and could save millions of pounds for the NHS by ensuring that the patients' are healthy, and remain out of hospitals.
  • Vectorious' V-LAP is the world's very first battery-less, wireless, digital device that can interact from within the patient's body using waveform morphology of high resolution.
  • According to Cardio Vascular Center Frankfurt's director, Prof. Horst Sievert, who performed the very 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.”

Future of the Product/Company

  • The second Vector-HF implantation procedure is scheduled to take place this month (October 2019) in Berlin.

IMPLANTABLE PERITONEAL ULTRAFILTRATION DEVICE (IPUD)

Overview

  • The Implantable Peritoneal Ultrafiltration device (IPUD) developed by Paragate Medical is a laparoscopically implanted system that is minimally invasive that serves as a mechanical bypass to the patient's kidneys.
  • Dr. Yair Feld, the co-founder and medical director at Paragate Medical, was first inspired by the notion of a parallel gate and developed a device to provide continuous relief for the clinical symptoms that congestive heart failure patients experience.
  • IPUD is found to function 24/7 non-aggressively and clears up the patient's "systemic excess fluid into the bladder, in a controlled and configurable manner".
  • IPUD consists of a smart control unit that can be recharged wirelessly once every week.

Current State

  • Company executives have announced that clinical tests for the product will commence later this year (2019) in Wroclaw, Poland, in partnership with Prof. Piotr Ponikowsky, a leading cardiology specialist.
  • IPUD is an ongoing project currently at the second phase with a grant agreement from Europe that started on 1 August 2019 and will end on 31 July 2021.
  • During the second phase of this project, Paragate is expected to scale-up production, execute verification and validation activities including a preclinical study, and validate the efficacy and safety of the device in a pilot clinical trial.

Pros/Cons

  • IPUD claims to improve patients' quality of life by eliminating recurring hospitalizations along with a more effectual treatment. It is found that healthcare systems will be able to significantly reduce the cost for frequent treatments and hospitalizations, equivalent to over €100 billion per year.
  • IPUD has already obtained backing from various medical experts like Prof. Uri Elkayam, Dr. Maria Rosa Costanzo, and the director-general of Rambam Medical Center, Prof. Rafael Beyar.
  • According to Prof. Rafael Beyar, “The method of Paragate to remove body fluids is an amazing, groundbreaking technology”.

Impact and Disruption

  • Paragate's founders claim that IPUD's ability to operate outside the hospital could have an overall positive financial impact.
  • Paragate’s IPUD will be utilized by a cardiologist only when a patient fails to respond to traditional and conventional oral diuretics such as “water pills”.
  • Through clinical trials, it was found that the device has the ability to transform the way congestive heart failure patients are treated. Both healthcare providers and patients will greatly benefit from shifting the treatment from hospital admissions to continuous care given at home.

Future of the Product/Company

  • According to the CEO of Paragate, Mr. Hanani — “In the future, the system may be able to utilize the remotely sensed data to operate in a fully autonomous mode”.
Sources
Sources