Boston Scientific wins CE Mark for Watchman FLX anti-stroke implant

Boston Scientific's Watchman FLXBoston Scientific (NYSE:BSX) said today that it won CE Mark approval in the European Union for the next iteration of its Watchman anti-stroke heart implant.

The Marlborough, Mass.-based medical device maker said the Watchman FLX is designed to be easier to implant during procedures to occlude the left atrial appendage and is re-capturable and re-positionable intraprocedurally.

Watchman FLX is under limited release in Europe, with more sites slated to come on line during the second half of the year, Boston Scientific said. A European post-market registry study is also planned, the company said.

“The Watchman device has been implanted in more than 75,000 patients worldwide and we are pleased that this next-generation technology has been granted European regulatory approval so that we can offer it to patients and clinicians throughout Europe,” interventional cardiology president Kevin Ballinger said in prepared remarks. “The robust clinical evidence and successful commercial outcomes of the Watchman device to-date reinforce the value of this procedure for all appropriate patients.”

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Perfuze raises $3m seed round for Millipede stroke catheter

PerfuzePerfuze said today that it raised more than $3 million for the Millipede catheter it’s developing to treat ischemic stroke.

Although not quite in stealth mode, the Galway, Ireland-based firm is close-mouthed about its technology. CEO Wayne Allen and CTO Liam Mullins (who co-founded Embo Medical before its  in 2015,  $YY acquisition by C.R. Bard in 2015) founded Perfuze last year.

The €3 million ($3.4 million) seed round, earmarked for Millipede development, was led by European VC shop Earlybird. MedFocus, Enterprise Ireland and an Irish syndicate of medtech veterans and stroke physicians also participated, Perfuze said.

“We are delighted to have completed our seed-round financing with such reputable investors and look forward to working together to accelerate the growth and value of Perfuze,” Allen said in prepared remarks.

“Perfuze has a technology with the potential to significantly improve outcomes for stroke patients,” added Earlybird partner John Yianni. “We are delighted to offer our financial and commercial support in helping this exciting company grow and get its life-saving technology to market.”

($1 = €0.876001)

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The top 10 medical disruptors of 2019


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The Cleveland Clinic for the past 16 years has predicted what the top 10 medical disruptors will be for the following year.

The health provider seeks input from 150 to 200 of its physicians, hailing from each of its institutes. The result is 300 to 400 suggestions, which the clinic then narrows down to 150.

After that, 20 physicians meet and vote the list down to the top 10. The criteria to be considered a disruptor is that it has to be so innovative that it could change healthcare in a significant way in the next year.

The Cleveland Clinic announced this year’s top 10 list at its Cleveland Clinic Medical Innovation Summit, which took place Oct. 22-24 in Cleveland. From RNA-based therapies to alternative pain therapy to fight the opioid crisis, here are the Cleveland Clinic’s predictions of medical technologies that will prove disruptive in 2019.

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Stryker wins expanded CE Mark for Trevo stent retriever

Stryker (NYSE:SYK) said today that it won an expanded CE Mark indication in the European Union for its Trevo thrombectomy device as a front-line treatment for acute ischemic stroke patients for up to 24 hours from symptom onset.

The expanded indication lifts the previously cleared treatment window by 18 hours, according to the Kalamazoo, Mich.-based company, and follows a similar move in February by the FDA.

“Along with the expanded indication in the U.S., this expanded indication for Trevo in Europe marks a significant milestone in the treatment of stroke patients who suffer from this disease,” neurovascular president Mark Paul said in prepared remarks. “We believed this future was possible, which is why we invested in the Dawn trial. Through our dedication to help patients suffering from ischemic stroke, we are living our mission to make healthcare better.”

“This is a big step forward, expanding the proportion of eligible patients for mechanical thrombectomy,” added Dr. Urs Fischer of the University Hospital of Bern, Switzerland. “For patients with a stroke of an unknown time of symptom onset or a wake-up stroke, a new therapeutic option is now available. However, mechanical thrombectomy should still be performed as quickly as possible, as numerous studies have shown that stroke patients treated early after symptom onset have a better outcome than patients treated late.”

“FDA clearance and CE approval of the Trevo Retriever have effectively quadrupled the treatment window from zero-six hours to zero-24 hours from time last seen well. Nonetheless, every minute still matters because in each individual patient, the earlier the blood flow is restored to the brain, the lower the resultant burden of permanent brain damage. Therefore, it is still imperative that all caregivers in the stroke pathway – from EMS to emergency room physicians to stroke neurologists to interventionalists – continue to deliver the fastest and most workflow-efficient treatment of stroke,” noted Dr. Tudor Jovin of the University of Pittsburgh Medical Center.

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Study of medication adherence with AI-supported selfies highlights potential for clinical trials

AiCure’s tool uses a form of artificial intelligence for facial recognition to confirm that patients have taken the correct medication.

MedyMatch, Samsung NeuroLogica bring AI to stroke care

Artificial intelligence is continuing to make its mark in the healthcare field.

Tel Aviv, Israel-based MedyMatch Technology and Danvers, Massachusetts-based Samsung NeuroLogica have joined forces to use artificial intelligence to assist patients in prehospital environments.

MedyMatch is an artificial intelligence company. “Our business is based on machine learning,” MedyMatch CEO Gene Saragnese said in a phone interview with MedCity.


Samsung NeuroLogica is the healthcare subsidiary of Samsung Electronics. “NeuroLogica has been in the CT business for many years,” Saragnese said.

The alliance, which brings together MedyMatch’s AI clinical decision support tools and Samsung NeuroLogica’s medical imaging hardware, was a smart move for the companies, according to Saragnese. “There’s a strong overlap between the two companies,” he said.

Initially, the companies plan to focus on assessing stroke patients. MedyMatch’s AI technologies will be integrated into mobile stroke units and other emergency vehicles that have a portable Samsung NeuroLogica CereTom CT scanner. Through this, the care team will more easily be able to assess whether the patient’s stroke is due to a hemorrhage or a blood clot.

Many of the nearly 800,000 Americans who experience a stroke each year have an ischemic stroke, which can be treated with a tissue plasminogen activator. The tPA must be administered to the patient within three hours of initial signs of stroke, but “it can take an hour after a stroke patient arrives in the emergency department to receive treatment because of the time needed to determine which kind of stroke the patient is having,” the companies point out in a release. By collaborating, MedyMatch and Samsung NeuroLogica are hoping to quicken the treatment process for stroke patients en route to the hospital.

“In stroke care, time is absolutely critical,” Saragnese said. “We want to improve the confidence physicians have in making these decisions.”

But MedyMatch’s goal goes farther than that. Saragnese told MedCity that MedyMatch strives to improve clinical outcomes and ultimately save money. “What we want to do is improve the quality of diagnosis and speed of treatment, and more people will recover from stroke,” he said. “There will also be fewer people in long-term care, and then there will be cost savings.”

MedyMatch launched in February 2016. Though it’s a startup, the company has already begun to make its mark in the healthcare field. Last June, it partnered with Capital Health in New Jersey. Capital Health vowed to help MedyMatch develop a clinical decision support tool for stroke care.

Photo: John Lund, Getty Images

AliveCor launches clinical app with AI function for early detection of AFib to prevent stroke

Screenshot from AliveCor Kardia Pro app for clinicians from AliveCor.

AliveCor, which has developed an FDA-cleared smartphone-enabled ECG device, has launched a clinician-facing app using artificial intelligence to pick up signs of atrial fibrillation earlier, according to a company news release. It’s an interesting development for the business because it can alert physicians to patients with an elevated risk of having a stroke.

The Kardia Pro app is for clinical use. But the goal is to analyze data from patients that includes weight, activity and blood pressure with AI to personalize the heart profiles of each patient, the news release said.


Last year, AliveCor partnered with Omron Healthcare to add Omron’s hypertension screening capabilities to AliveCor’s app.

An estimated 795,000 people suffer a stroke each year, the majority of them for the first time. If you factor in hospitalization, medications and time off of work, strokes cost the U.S. roughly $33 billion each year, according to data from the Centers for Disease Control.

AliveCor also closed a $30 million Series D round led by Omron Healthcare and Mayo Clinic. The funding will be used to speed up innovation in heart health and grow the business.

The launch of the company’s Kardia Pro app is an important milestone for AliveCor. But at a time when the hype around AI has reached a fever pitch, clinical validation will be critical to demonstrate how effective the company is at spotting early signs of life-threatening conditions such as stroke and whether these interventions improve patient outcomes.

Features Photo: Bigstock