WhiteSwell, a medtech company based in Galway, Ireland, has developed a catheter system to treat acute decompensated heart failure (ADHF).
ADHF is often treated using diuretics to remove excess fluid, but this doesn’t work for every patient and can have side-effects.
This latest technology consists of a catheter with an impeller pump that is designed to stimulate lymphatic drainage, and thereby aid with decongestion without the need for diuretics. The catheter creates an area of low pressure where the largest lymph vessel, the thoracic duct, connects with the venous system near the heart.
WhiteSwell claims that the technology could help to completely and rapidly decongest ADHF patients, and it can protect patient kidney function. The company recently announced a US patent for the device, and has conducted early feasibility studies in humans.
Medgadget had the opportunity to talk with Eamon Brady, CEO of WhiteSwell about the technology.
Conn Hastings, Medgadget: Please give us an overview of acute decompensated heart failure and its consequences for patients.
Eamon Brady, WhiteSwell: Acute decompensated heart failure, or ADHF, is a serious clinical event wherein the body is not able to cope with a weakening heart that is unable to pump enough blood to meet the body’s needs. In the vast majority of cases, patients suffer from systemic congestion which impairs blood flow to the organs thus jeopardizing organ function. Immediate treatment focuses on decongestion to remove the excess fluid. Inadequate decongestion (residual congestion) is a strong predictor of rehospitalization and death. As many as half of ADHF patients are discharged from the hospital not fully decongested, and about 25% are readmitted to the hospital within one month, and half are readmitted within six months.
Patients with ADHF experience difficulty breathing, fatigue, and swelling (edema) due to fluid back-up in the lungs and other parts of the body (congestion). Increases in body weight are often associated with acute heart failure hospitalization and can begin at least a week before presentation. Of those who are hospitalized as a result of acute heart failure, more than 90% are suffering from congestion.
About 5.8 million people in the U.S. and over 15 million people in Europe (23 million people globally) have heart failure, and ADHF contributes to nearly three million hospitalizations each year in the U.S. alone.
Medgadget: How is the condition treated at present?
Eamon Brady: ADHF requires immediate treatment to remove excess fluid in a process called decongestion. Therapeutic strategies to manage ADHF include intravenous diuretics and vasodilators (medications that open blood vessels). Inotropes and other approaches may be used to support heart function in some cases.
Medgadget: What are the limitations of current treatment approaches?
Eamon Brady: More effective treatments for ADHF are needed. Some patients respond well to intravenous diuretic therapy, but many do not. If decongestion is not progressing as planned, the dose can be increased or additional types of diuretics and other medications may be used. Overly aggressive diuresis can result in hypotension and leads to a worsening of kidney function. The length of time required to decongest a patient is also impacted by the amount of excess fluid in their body when they were hospitalized.
Current approaches focus on moving fluid out of the blood vessels (vascular space) through the kidney by using diuretics. However, when the body is overloaded with fluid, most of the excess fluid is not actually in the vascular space but is instead located in the tissues, specifically in the spaces surrounding the cells in the tissue called the interstitium. In order to fully decongest the patient, the excess fluid in the interstitium needs first to be moved into the vascular space. In a healthy person, this function is performed by the massive drainage network of the lymphatic system which actively drains the fluid into the great veins just above the heart. However, for ADHF patients, the pressure in the great veins can be high and can slow or even stop the flow of lymph fluid into the great veins, thus hindering the decongestion process.
Medgadget: How did you get involved in this area? What drew you to develop this catheter technology?
Eamon Brady: WhiteSwell was founded in 2014 with the recognition that little had been done to change the approach to treating ADHF in recent decades. Two insights arising from our team’s research on the lymphatic system sparked an innovation process that led to the development of our solution. The first was recognizing that lymphatic function is critical to draining excess interstitial fluid and the second was that the normal drainage function of the lymphatic system is significantly inhibited in most patients with ADHF.
What captured my imagination was the fact that an amazingly elegant and complex system such as the lymphatic system had been overlooked and underappreciated by many for so long and yet has such an impact on patient health. With such a significant need for improvement in treating ADHF patients, I was drawn to the potential of leveraging the lymphatic system to deliver better therapy to these patients.
Prior to joining WhiteSwell, I was the founder and CEO of Neuravi for eight years. A passion for driving device development with great science was rewarded there as we used new insights discovered from the study of blood clots that cause ischemic stroke to develop advanced technology to remove those clots. After selling Neuravi to Johnson & Johnson, who brought the technology to patients worldwide, I had planned to take my time exploring a variety of opportunities. However, within a few weeks, the opportunity at WhiteSwell was presented and I simply couldn’t let it pass. The combination of a huge unmet clinical need and the intrigue of the science of lymphatic and interstitial fluid dynamics captured my imagination. The innovative team had demonstrated compelling proof of concept in animals and with early feasibility human work, and I could see the potential of the technology and the science to greatly impact on patient care.
Medgadget: How does the system work?
Eamon Brady: WhiteSwell directly targets the excess fluid in the body’s tissues and we use the incredible drainage power of the lymphatic system to do so. WhiteSwell’s therapy aims to facilitate interstitial decongestion in parallel with diuresis of the vascular compartment. The therapy works by creating a localized low-pressure zone where lymph fluid from the biggest lymph vessel, the thoracic duct, enters the venous system slightly above the heart. A unique and proprietary catheter system is introduced into the veins to create a low-pressure region, facilitating increased lymph drainage and enabling the simultaneous decongestion of the interstitial and vascular spaces. We believe this simultaneous approach has the potential to completely decongest more patients in a shorter time frame while protecting the patient’s kidney function.
Medgadget: Have you conducted any clinical trials of the device, or do you have any planned in the near future? When do you envisage that the technology might be available?
Eamon Brady: Results for nine patients from an early feasibility study were previously presented at the TCT Conference. Results demonstrated no device-related adverse events and no hospital readmissions at 30 days, which are supportive of the device’s safety. The results are promising, and our learning from this clinical experience has led to technology enhancements intended to simplify the procedure. We look forward to continuing early feasibility clinical evaluation with our enhanced technology platform later this year. From there we will move forward with more extensive clinical trials to demonstrate safety and efficacy.
Link: WhiteSwell homepage…