Many people, both healthy and sick, use wearable devices to monitor their body and track their health. It’s common knowledge that the readings from these devices won’t be the most accurate in the world, but under the right circumstances they can provide interesting titbits about how a person is doing physically. But when it comes to monitoring serious health conditions, patients need something more heavy-duty.
Around 26 million people worldwide live with heart failure, where the muscles of the heart struggle to pump blood around the body. All people with chronic heart failure will need monitoring, but it can be hard to predict when adverse events arising from the condition will occur until they’re already happening.
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Enter Vectorious. The Israeli medtech company has developed the world’s first in-heart computerised device, the V-LAP. V-LAP is a miniature, wireless, battery-free microcomputer that rests directly on the heart’s interatrial septum and provides precise pressure readings to patients and clinicians at the push of a button.
The data is passed through an accompanying portable belt, which wirelessly syncs with the implant and then transmits information from the device securely into the cloud. Using artificial intelligence (AI), clinicians can see a preventative analysis of any heart anomalies, detecting potential risks before they occur and helping to prevent them.
Verdict Medical Devices caught up with Vectorious medical director Dr Leor Perl to learn more about the implantable blood pressure monitor.
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By GlobalDataChloe Kent: How does the V-LAP device work?
Leor Perl: The V-LAP is silent and does not work throughout the day unless it is being activated by an external unit. The external unit does two main things – one, it transmits energy by inductive coupling to the implant, creating a situation where the implant begins measuring pressure. It can give you information on the heart rate, temperature, pressure rating. It holds a lot of information because it’s a high-fidelity, high-resolution waveform each beat.
The implant has a computer within it, there’s an AC chip, and it corrects for drift, which is a major issue with biological tissues in general. The data is then transmitted out into the external belt, which sends the information to the cloud. Clinicians can then get a pressure reading remotely, with heart rate and the temperature and so on, anywhere in the world.
CK: What is this experience like for a patient?
LP: It’s a tremendous change. The patient does have to undergo the implantation procedure. It takes minutes; it’s a minimally invasive procedure. We get some local anaesthesia and we go through the femoral vein via a needle into the heart and implant it there. It’s a miniature device, it’s 2.5 millimetres in diameter, and it’s anchored to the interatrial septum, so it just sits there like any other device that’s being implanted in the heart.
Assuming the patient is compliant, measuring pressure once or twice a day, this data is transmitted to the team that takes care of these patients. Remember, these are patients with heart failure, who have a very high risk of being admitted to hospital once again. Heart failure is the number one condition in terms of the risk of readmissions. These are patients who come in and out of the hospitals, usually with severe symptoms of shortness of breath, they feel like they basically are being strangled to death. It’s a very scary, uncomfortable, bad place to be at when they become admitted. This device from now on will foresee these acute exacerbations in heart failure where there is a risk for an acute heart failure event like that.
CK: Would you say your product represents a shift in how to approach patient care?
LP: It’s a whole new world. It’s a completely different way of treating these patients. Imagine trying to balance patients with diabetes without having glucose monitors. Treating patients with heart failure without having knowledge of the pressure within the cardiovascular system has been shown scientifically to be inaccurate. What they do presently is they measure weight, they look at symptoms and that’s how medications have been titrated. Now we have objective, actionable data that shows us how to treat these patients.
CK: How do you feel the Covid-19 pandemic has impacted remote monitoring technologies like yours?
LP: Like many other crises in the past, humanity is going to grow. One of the things in the medical device world that I think people are appreciating now is that patients don’t necessarily have to come into the hospital for some of the things that we’ve been doing. In fact, it’s probably better if they stay at home, with or without the pandemic. That’s been the case that we’ve been trying to make for years, because admissions in the US and the UK are very expensive, and it can actually be dangerous to come into the hospital when you have heart failure or other chronic diseases.
There’s been a change in the reimbursement strategies of many of the healthcare organisations to try and mitigate some of this flow into the hospital. Some physicians and some hospitals are looking at admissions actually, as a complementary event to the maintenance of care that we can perform at home.
CK: What do you see as the future of remote care post-pandemic?
LP: Things are not going to be what they used to be. The whole strategy of the hospital is going to change. In the world of telemonitoring, I think this is going to be the dawn of remote patient care. We have to realise that not all wearables and remote data is useful. To actually use data to care for these patients, physicians have to go through regulated medical devices that have been shown to pinpoint valuable information and we can treat these patients according to that data, which has been scientifically proven and legally regulated.
I think that 10 years from now, many chronic conditions, and maybe some acute ones, will be diagnosed, monitored and treated according to multiple sensors. Patients with chronic lung disease, cancer, chronic pain, neurological conditions – these patients can benefit a lot from data that comes from remote monitoring. That’s going to be a huge shift because it requires infrastructure, it requires new training for the medical staff, but it’s going to make life easier and safer for patients.
CK: So you’re seeing medicine shifting more towards prevention than cure?
LP: I’m just going to throw in a crazy thought. Imagine a future where 20 years from now all babies born in the UK and Israel and the US are implanted with completely safe, durable and efficient sensors that can let you know when they’re at risk for things like sudden infant death syndrome, or when they’re having an allergic reaction or fever. And then as you become older, you go in during your puberty to get your puberty chip implanted and that lets you know when your cholesterol goes up, or if you’re going into a risk category for diabetes. It sounds crazy, but I do think that our children will have that opportunity.
CK: I can see a lot of people being very averse to what you’ve suggested there – how would you convince them it’s a good idea?
LP: Oh, yeah, there’ll be some pushback. It has to be regulated, has to be safe. But this is not to invade privacy and to know where you are, but to have information on disease to protect us.
