Boston Scientific acquires Claret Medical, Inc.
Global medical technology leader, Boston Scientific, has acquired privately held company Claret Medical, Inc. the price consists of $220 million in up-front cash, as well as a potential reimbursement-based milestone payment of up to $50 million.
Renowned for developing and commercialising the Sentinel Cerebral Embolic Protection System, used in neurosurgical procedures, such as transcatheter aortic valve replacement (TAVR), the system is the only device cleared to protect patients against the risk of stroke during TAVR and received CE Mark in 2014 and FDA clearance in 2017.
TAVR remains a minimally-invasive procedure, where the aortic valve is replaced in patients with severe aortic stenosis. Embolic debris such as calcium or tissue can break loose during the procedure, travel through the bloodstream towards the brain and potentially cause neurological and neurocognitive damage. Recent studies have estimated approximately four percent of patients experience a clinically-apparent stroke within 30 days of a TAVR procedure.
"Through the development and commercialisation of the Sentinel System, Claret Medical has successfully introduced a new layer of safety and peace of mind for physicians and their patients undergoing TAVR procedures," explained Kevin Ballinger, President, Interventional Cardiology, Boston Scientific.
- Robert Chu, CEO and Founder of Embleema, discusses the launch of its blockchain health records
- Ascletis Pharma becomes the first biotech to file an IPO in Hong Kong
- Airbus and International SOS collaborate on drone cargo medical delivery systems
"This acquisition will expand our commercial portfolio to include an important adjunctive offering aimed at improving TAVR patient outcomes. We also see potential for future use in other left heart and endovascular procedures such as mitral valve repair and replacement, left atrial appendage closure and pulmonary vein isolation ablation procedures for atrial fibrillation."
In a pivotal SENTINEL trial, the landmark study that led to FDA clearance and commercial introduction of this first-time therapy in the US, the Sentinel System reduced the incidence of strokes by 63% within the first 72 hours of the procedure. In clinical studies, the Sentinel System captured debris flowing towards the brain in 99% of TAVR cases.
"Nearly 10,000 patients have been treated worldwide with the Sentinel System, and we are confident that the leadership of Boston Scientific will enable increased momentum and improved patient access to this valuable technology," stated Azin Parhizgar, PhD, President and Chief Executive Officer, Claret Medical.
The acquisition is projected to close during the third quarter of 2018, subject to customary closing conditions.
The deal follows on from Boston Scientific’s acquisition of Cryterion Medical, where the company aims to further its atrial fibrillation ablation therapy offerings by utilising its ground-breaking cryoballoon platform. The company has been investing in Cryterion since its establishment in 2016, where the system is currently undergoing clinical studies in Europe, with the aim to gain CE and FDA approval.
Long haul Covid, the brain and digital therapies
It is estimated that around 10% of people who get Covid-19 develop long haul Covid, a debilitating condition that can last many months and cause breathlessness, exhaustion and pain.
Research is underway to find out who is more likely to get it and how to treat it. Here neuroplasticity expert and owner of Harley Street Solutions in London Ashok Gupta tells us how the condition affects the brain.
What is long Covid exactly?
Long Covid is when patients who have experienced Covid-19 go on to have continuing symptoms for weeks and months afterwards. These symptoms can include breathlessness, exhaustion, brain fog, gastric issues, pain, and post-exertional malaise. It is estimated that around 10% of Covid-19 infections may result in developing long haul symptoms, and in the USA, this may be affecting over 3 million people.
How does it affect the brain?
Here at our clinic, we hypothesise that it is due to a malfunction in the unconscious brain, creating a conditioned response that keeps the body in a hyper-aroused state of defensiveness. At the core of this hypothesis is the idea that we are here because our nervous system and immune system have evolved to survive. We are survival machines!
When we encounter something such as Covid-19, the brain perceives it as life threatening, and rightly so. And in the era of the pandemic, with more stress, anxiety and social isolation, our immunity may be compromised, and therefore it may take longer for the immune system to fight off the virus and recover.
If the brain makes the decision that this is potentially life threatening and we get to the stage where we’re overcoming the virus, a legacy is left in the brain; it keeps over-responding to anything that reminds us of the virus. Even if we’ve fought off the virus, the brain will react in a precautionary way to stimuli reminiscent of the virus.
The brain may get stuck in that overprotective response, and keeps stimulating our nervous system and our immune system, just in case the virus may still be present.
What symptoms does this cause?
These signals cause a cascade of symptoms including breathlessness, extreme fatigue, brain fog, loss of taste or smell, headaches, and many others. And these are caused by our own immunes system.
In the case of long-haul Covid, symptoms in the body get detected by a hypersensitive brain which thinks we’re still in danger. The brain then chronically stimulates the immune and nervous systems, and then we have a continuation of a chronic set of symptoms.
This isn’t unique to long-haul Covid. Many patients develop chronic fatigue syndrome, sometimes known as “ME”, for example, after the flu, a stomach bug, or respiratory illness. Covid-19 may be a severe trigger of a form of chronic fatigue syndrome or ME.
How does long-haul Covid affect mental health?
Anxiety is a very common symptom in long haulers. It can be frightening to wonder about what may be happening in your body, and what the prognosis is going to be for one’s long term health. Reaching out for support for mental health is crucial for long-haulers.
How does neuroplasticity treatment work for long-haul COVID patients?
We have been working with patients for two decades with a brain retraining programme using neuroplasticity or “limbic retraining.”
We believe that through neural rewiring, the brain can be “persuaded” that we are no longer in danger and to come back to homeostasis. But to be very clear, we are not saying it is psychological in any way, but we believe there are novel ways of accessing the unconscious brain.
We recently worked successfully with a 56-year-old male with long-haul Covid, who prior to contracting Covid-19 in March of 2020 was running half-marathons and cycling, but afterwards he struggled to get off the sofa for months. Within 3 months he’s now back to 100% and running half marathons again.
At our clinic, we train the patient to be able to recognise those subtle unconscious danger signals on the periphery of consciousness. This, coupled with supportive techniques and the natural hallmarks of good health such as sleep and diet help prepare the patient to respond to perceived threats that might trigger the response.
The natural state of our brain is to default to protection. The brain prioritises survival and passing on our genes to the next generation, over any other impulse. It cares more about that than you feeling healthy and well. Protective responses are evolutionary, and are the right thing for the brain to do – it’s survival.
What digital therapies or apps are proving effective at treating long-haul Covid?
It seems that long haul patients are availing themselves of many online therapies and services, including meditation apps and wellness websites. We have an online neuroplasticity “brain retraining” video course called the “Gupta Program” which hosts 15 interactive videos and many audio exercises. This is proving very popular with long haul patients, and we are currently conducting a trial to test the effectiveness of this therapy.
What is the danger of leaving long-haul Covid untreated?
The longer it goes untreated, we hypothesise that it may become more entrenched in the brain, and become chronic in the longer term. Therefore we advise all patients to get help and advice as soon as possible.