It is brutal and very expensive to bring a new transcatheter valve to market. Boston Scientific invested vast amounts of resources to bring the Lotus transcatheter aortic valve replacement (TAVR) device to the U.S. market. However, the vendor found the Lotus lagged so far behind the first-to-market TAVR valves (the Edwards Lifesciences Sapien and the Medtronic CoreValve) that it was not worth further investment and removed the Lotus from the market in November 2020. The company found it was very difficult to compete with two other TAVR valve vendors that learned from clinical experience and redesigned their valves several times to make them better.

However, Boston Scientific was not out of the structural heart valve space, having also invested in the Acurate neo self-expanding valve in tandem with the Lotus as a next generation TAVR device. The company was confident in the valve’s abilities and went head-to-head in two trials against the Sapien and the CoreValve to show it could produce the same, or better, outcomes. It failed to do so in both when the final results for the SCOPE I and SCOPE II trials were presented at the Transcatheter Cardiolvascular Therapeutics (TCT) 2019 meeting. There was a high level of moderate paravalvular leaks (PVL), which was a bitter pill to swallow when the other two FDA-cleared valves had already largely solved this issue with several design changes.

Boston Scientific was so impacted by the negative results, they asked me not to use any photos or video I had shot of the Acurate neo valve in their works-in-progress area of their booth at TCT that year. They originally wanted to promote the new valve at TCT, but quickly pulled back on that when the data from the SCOPE trials was less than favorable.

But, the company remained optimistic that its latest iteration of the valve, the Acurate neo2, would offer better results. They were right.

Even in those head-to-head trials, the vendor already knew there were issues with PVL in the first generation of the device. By the time the results of the SCOPE studies were delivered, the company had already redesigned the Acurate neo to enlarge its sealing skirt, making it 60 percent larger on the Acurate neo2 iteration of the valve. This same PLV issue was encountered in trials by Edwards with its Sapien valve, leading to the newer, current iterations of that valve with a larger sealing skirt.

However, while PVL was a problem for the first generation Acurate neo, it was noted that stroke rates with the device were lower than with the current FDA cleared devices. The Acurate neo was originally designed with lowering pacemaker rates in mind, so this part of the valve worked out.

The PVL issue now appears to be solved, with the most recent Acurate neo2 data presented at hotline and late-breaking trial sessions at the EuroPCR 2021 congress in May. The device demonstrated positive procedural performance, including low rates of PVL and permanent pacemaker implementation (PPI). The new data was reflected in the investigator-initiated Early neo2 Registry and ITAL-neo Registry studies.

The Early neo2 Registry, presented by Andreas Rück, M.D., Ph.D., interventional cardiologist, Karolinska University Hospital Stockholm, is the first large real-world report of clinical experience with the Acurate neo2 device. Key findings from this retrospective analysis of 554 patients from 12 European centers included:
• 1.3 percent post-operative moderate/severe PVL rate which was lower than the rate observed in prior studies with the Acurate neo device. The mild and none/trace PVL rates were 33.3 percent and 65.4 percent, respectively.
• 6 percent in-hospital PPI rate
• 2.1 percent in-hospital stroke rate
• 1.3 percent mortality rate at 30 days and excellent hemodynamics (mean gradient of 9 mmHg)

The retrospective ITAL-neo Registry was presented by Andrea Buono, M.D., MBBS, an interventional cardiologist at Fondazione Poliambulanza Istituto Ospedaliero in Brescia, Italy. It included 95 TAVI patients from nine Italian centers and evaluated in-hospital device success and in-hospital patient outcomes with the Acurate neo2 device. Key findings included:
• 3.1 percent pre-discharge moderate/severe PVL rate. This rate, in addition to the mild and none/trace PVL rates (56.9 percent and 40 percent), was lower than previously reported rates in studies of the Acurate neo device.
• 97.9 percent device success rate.
• 1.1 percent in-hospital stroke rate.
• 11.2 percent in-hospital new PPI rate and excellent hemodynamics (pre-discharge mean gradient of 8.2 mmHg).

Vendors are constantly trying to develop a better mouse trap. It is possible the Acurate neo2 might be that device in TAVR. But, it will require a rematch similar to the SCOPE trials to show if the newest iteration of the device can now meet or exceed the performance of the two current generation FDA-cleared valves.

Entering the U.S. TAVR market is important because in the U.S., TAVR now makes up more than 50 percent of the aortic valve replacement procedures and volume is still rising, eroding surgical volume. A device with improved outcomes and less need for a permanent pacemaker could tip the balance in market share in the coming years.

Boston Scientific Makes a Comeback With Positive Clinical Data for its Second Iteration Acurate neo2 TAVR Valve

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Being involved in a car accident can leave you confused and disoriented. The impact of the crash can not only cause you physical injury but also affect you mentally. While there is always a chance of being in a car accident, following the rules can greatly reduce the probability of it. In addition to this, one must be informed about the things that need to be taken care of immediately after an accident. In this article, you’ll discover some important things you need to do to protect yourself after a car accident.

1.  Check For Injuries

When you’re involved in a car accident, the intensity of the experience pumps you up with adrenaline for a few moments. Even if you’re badly injured, you won’t realize the pain for some time. This is the reason why the first thing you should do immediately after an accident is to check yourself for injuries. However, you mustn’t make any sudden movements. Look for signs of blood or cuts on your body. In addition to this, try moving your body parts slowly. If you feel severe pain in any part of your body, stop moving completely and wait for help to arrive. With that said, if you see no signs of injury, check on your fellow passengers, if any. In addition, if there was another vehicle involved in the accident, you must check up on the other driver as well.

2.  Get To Safety

If your car meets with an accident on a freeway, chances are high that other vehicles will pass by. After ensuring that you’re not injured and capable of moving on your own, you must get to the side of the road and away from harm’s way. Many freeway accidents result in chain reaction accidents where multiple vehicles collide into the crashed vehicles. It is best to get away from your vehicle as soon as possible. If somebody is injured in the accident, help them get to safety, as well. However, if their injury seems too deep, do not move them from their place. Get yourself to safety and wait for help to arrive.

3.  Call the Emergency Number

If you have a car accident on a busy route, somebody may have already informed the local authorities. However, once you get away from the site of the accident and on the side of the road, calm yourself down and call the emergency contact number. You will need to explain the situation to them and provide your location. Once the help arrives, get yourself checked for injuries or concussions. In most cases, you will need to file a complaint to the local authorities. The local police will help you with the legal formalities. The filling of a complaint is best done immediately after an accident because that’s when the memory is the freshest. If you take too much time in filling a complaint, you may forget some details that could have helped you with your case.

4.  Document The Details

Once you’ve ascertained that nobody was seriously injured, you should note down the details of the accident. Make sure to include as much detail as possible. If there was another car involved in the accident, you should document the license plate number and driver’s name. In addition to this, you should take the details of the driver’s insurance company. It will come in handy later in the proceedings. With that said, it is best to avoid discussing who was at fault. Leave that to your attorney.

5.  Personal Injury Lawyer

If you’re ever involved in a car accident, the stress of the situation can make you experience a whirlpool of emotions. The accident does not only affect you physically but also has an emotional and financial impact. You must hire a good personal injury attorney to help you recover from the aftermath of the accident. A good lawyer will help you file a lawsuit, be your representative in court, and negotiate for the claims on your behalf. While your injury lawyer takes care of business, you can recover in peace without having to worry about the legal processes.

To summarize this article, let us go through the key takeaways. If you’re involved in a car crash, The first thing you need to do is to check for injuries on your body and that of your passengers. Once you’ve ensured that nobody involved in the accident is seriously injured, get to a safe place away from the road. Call the emergency number and file a complaint. It is best to hire an expert personal injury attorney to take care of your claims.

Vyaire Medical, the world’s largest medical device maker fully dedicated to improving breathing for every person around the world, announced the development of a new comprehensive digital tool designed to arm clinicians with the data and insights they need to better manage breathing for critically ill patients. Vyaire Messenger is a novel mobile application that securely provides patient status information and meaningful clinical insights directly to the respiratory therapist via their mobile devices. Vyaire Messenger is intended to reduce the burden on clinicians by providing visibility to all ventilated patients simultaneously so that they can prioritize and coordinate care. In addition, Vyaire Messenger will proactively notify clinicians should a patient experience a change in ventilation therapy, simplifying processes and prioritizing patients who need the most care.

“Vyaire is leveraging digital and connectivity technology to reimagine the needs of our customer base,” said Gaurav Agarwal, chief executive officer of Vyaire. “Our collective experience with COVID-19 has taught us that care must be delivered differently, such as the ability to better triage patients or monitor them outside the hospital room. We are committed to taking those lessons learned and delivering meaningful solutions that help clinicians provide care to those who need it most.”

Vyaire Messenger works seamlessly with the bellavista™ and Avea™ ventilation platforms via the Respiratory Knowledge Portal, a data application system released by Vyaire in 2015. The Vyaire Messenger is unique to market in that it is portable on mobile devices and gathers data from compatible IV pumps providing important clinical insights in sedation. Developed in partnership with customers on the front lines, Vyaire Messenger has the potential to significantly reduce the cost of care in the ICU by improving protocol adherence and coordination of clinical functions in order to reduce the amount of time patients spend on a ventilator. The Company released Vyaire Messenger last summer to a limited market and developed the current version based on customer testing and feedback. Clinical data gathered from that period enhances the Company’s thesis that Vyaire Messenger has the potential to improve multiple metrics & outcomes, including1:

78% of clinicians who agree that Vyaire Messenger has the potential to improve protocol adherence resulting in an improvement in ventilated patient outcomes;

83% of clinicians who agree that Vyaire Messenger has the potential to improve coordination of care between clinical functions resulting in the reduction of the incidences of ventilator associated events (VAE).

“Monitoring and prioritizing ventilated patients without these advanced technologies requires frequent bedside visits and coordination of care between various clinical specialties is a challenge,” said Tom Cahill, Respiratory Director at St. Elizabeth Healthcare in Kentucky. “Now, our clinicians can get real-time clinical insights for their patients right at their fingertips and improved communication within our care teams, which helps prioritize patient care and provide optimal patient management.”

With the availability of Vyaire Messenger, we are embarking on an exciting digital transformation journey,” continued Agarwal. “Vyaire engineers are hard at work contemplating how we will leverage digital and connectivity technology across sedation, diagnostics and ventilation platforms. We see exciting potential in this space that will help patients around the world take better breaths.”

About Vyaire Medical
Vyaire Medical Inc. is a global company focused exclusively on supporting breathing through every stage of life. Established from legacy brands with a 65-year history of pioneering breathing technology, the company’s portfolio of integrated solutions is designed to enable, enhance and extend lives. At Vyaire, we pledge to advance innovation and evolve what’s possible to ensure every breath is taken to its fullest. Headquartered in suburban Chicago, Vyaire is recognized, trusted and preferred by specialists throughout the respiratory community worldwide.

CarePort, powered by WellSky®, a market leader in care transitions, introduced CarePort Ambulatory, a solution that enables ambulatory providers, including physician offices, hospital outpatient departments, ambulatory surgical centers, specialty clinics, and urgent care centers, to improve collaboration with home- and community-based organizations and track patients across these settings. As hospitals become more reliant on ambulatory providers to support whole patient care, gaining insight into a patient’s care journey is critical to streamlining care transitions, achieving better patient outcomes, and improving quality of care at a lower total cost.

Through an electronic referral process, CarePort Ambulatory enables physician groups and other ambulatory providers to connect patients to home- and community-based organizations such as home health, durable medical equipment, transportation, food insecurity services, and physical therapy. Ambulatory providers can launch the referral tool directly from their electronic health record (EHR) to search a national database of services, maintain two-way communication throughout the referral process, and “close the loop” to ensure patients’ needs are met within their home or in the community.

“The CarePort platform takes away all of the manual detective work in transitional care management,” said Bill Johnjulio, M.D., chair, AHN Primary Care Institute and medical director, Physician Partners of Western Pennsylvania. “The platform provides us with the contextual information we need, in real-time, to better monitor patient transitions across the continuum of care.”

Integrating data from more than 1,000 CarePort customer hospitals and external data sources such as health information exchanges (HIEs), CarePort Ambulatory provides physicians with critical, real-time information to efficiently monitor patient discharges, transfers, and readmissions across the continuum and reengage with patients when needed. This increased visibility into patient status maximizes revenue opportunities for physician groups and other ambulatory providers under value-based care and transitional care management.

“As care is increasingly delivered outside the four walls of a hospital, physician groups and other ambulatory providers require the capabilities to support whole patient care,” said Lissy Hu, M.D., CarePort CEO and founder. “Our newest offering enables ambulatory providers to efficiently coordinate with home- or community-based organizations, and track and monitor care across settings – helping achieve the best possible outcomes for patients.”

About CarePort, powered by WellSky

CarePort is the leading care coordination network with thousands of providers connected across the U.S. The end-to-end platform bridges acute and post-acute EHR data, providing visibility into the entire patient journey for providers, physicians, payers, and ACOs. With CarePort, healthcare professionals can efficiently and effectively coordinate patient care to better track and manage patients as they move through the continuum. CarePort helps providers meet and comply with the patient event notification Condition of Participation, as part of the CMS Interoperability and Patient Access final rule, and the IMPACT Act.

Intertek, a leading Total Quality Assurance provider to industries worldwide, and Globizz, a leading Japanese-U.S. medical device consulting firm, have entered a partnership offering regulatory consulting, technical services, and strategic planning for medical device manufacturers in Japan and the United States. The agreement between the two companies will offer customers in both regions the expertise and resources for easier, more efficient market access, expanding the services for both companies, their existing customers, and others in the industry.

The United States and Japan are two of the largest medical device markets in the world. Japanese manufacturers looking to enter the U.S. market must be prepared to have their products meet requirements set by the U.S. Food and Drug Administration (FDA), Occupational Safety and Health Administration (OSHA), state regulatory bodies, and other entities. As a testing and certification company, Intertek experts can assist with evaluating products to standards, but the company required a partner to better assist with consultative services in the product development phase.

As a bilingual consulting group, Globizz is well-versed in requirements and prepared to assist clients as products are developed, assessed and certified for the U.S. The partnership will allow Intertek to expand its medical device services in Japan, helping medical electrical equipment and devices get to the U.S. market quickly and efficiently. Globizz will be able to tap Intertek’s extensive technical expertise, as well as testing and certification solutions, for its clients looking to enter the U.S. or Japan, expanding its services and market access.

Takahiro (Harry) Haruyama, President of Globizz, said, “For an overseas company to succeed in the medical device market in the US, it not only requires a good product but also the know-how of the intricacies of the medical device market and a trusted partner in the US for fruitful outcomes. We are honored to partner with such a well-known, world industry leader that adds to the level of trust and know-how and to leverage the relative strengths of each party’s services and resources to expand both parties’ business in the US and Japan.”

Sunny Rai, Senior Vice President at Intertek, said, “Intertek has always been focused on providing Total Quality Assurance solution through an extensive, knowledgeable network of experts who offer assurance, testing, inspection and certification services to our clients. We are pleased to partner with Globizz to bring much-needed consulting services to the medical device industry in both Japan and the U.S. We look forward to partnering with Globizz on bringing innovative, in-demand products to both markets.”

ABOUT INTERTEK

Total Quality. Assured.

Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories in more than 100 countries delivers innovative and bespoke Assurance, Testing, Inspection and Certification solutions for our customers’ operations and supply chains. Intertek Total Quality Assurance expertise, delivered consistently, with precision, pace and passion, enabling our customers to power ahead safely.

ABOUT GLOBIZZ

Globizz is a business consulting group, assisting both American and Japanese businesses, offering consulting services for Japan market expansion, strategic planning, and market research. As one of the first Japanese-English Bilingual FDA consulting firms, Globizz also has a division of business consulting for Japanese companies doing business in the United States, offering assistance in food, cosmetics, medical devices, drugs, and animal foods.

CyberMDX, a leading healthcare cybersecurity provider delivering visibility and threat prevention for medical devices and clinical networks, and  Alphatron Medical, announced a partnership to help manage cybersecurity risks and protect the data workflow for Alphatron Medical’s customers.

With the increased digitization of hospitals, Alphatron Medical offers various IT solutions, data workflows and medical workware, enabling healthcare professionals to work smoothly and comfortably throughout the entire care process. The company’s integrated approach helps healthcare delivery organizations (HDOs) manage today’s increasingly complex healthcare IT environments. Serving almost all hospitals in the Netherlands, as well as many in Belgium and Germany, Alphatron’s solutions help their customers maximize their IT systems and enable healthcare providers to focus on patient care.

The value of electronic personal health information (ePHI) has led to a dramatic rise in cyber-attacks against healthcare organizations and has emphasized the criticality of cybersecurity as a component of any healthcare organization’s IT strategy. The partnership will help improve the quality of security for Alphatron’s customers, utilizing CyberMDX’s Healthcare Security Suite to ensure the data security of Alphatron’s data management solutions. CyberMDX’s solution provides customers with endpoint visibility, network threat prevention, and operational analytics to any connected medical, IT, or IoT devices. The solution ensures healthcare delivery organizations (HDOs) can keep pace with the fast growing IT ecosystems and protect the vast amount of ePHI flowing through their networks and devices on a daily basis.

“With the intricacies of healthcare networks growing more complex by the day, partnerships to ensure the continued protection of critical data and medical infrastructure are vital,” said Amir Vashkover, AVP, Business Development & Strategic Alliances at CyberMDX. “Our partnership will further expand our presence in Europe, particularly in the Netherlands where Alphatron serves 95% of healthcare providers. It’s also going to give Alphatron customers access to an award winning IoT Security solution that significantly limits the attack surface and reduces likelihood of a successful breach.”

“The CyberMDX solution fits well into our portfolio of integrated medical IT workstations and image management and exchange products because it allows hospitals to simplify, secure and improve work processes within healthcare,” said Harald Verloop, CEO, Alphatron Medical. Unlike other IT assets, connected medical devices are often unprotected or unmanaged. Alphatron is taking its responsibility to make sure their customers have the ability to implement a state-of-the-art cybersecurity solution.”

About CyberMDX

CyberMDX is an IOT security leader dedicated to protecting the quality care of health delivery worldwide. CyberMDX provides cloud-based cybersecurity solutions that support the advancement of The Internet of Medical Things. The CyberMDX solution identifies endpoints and assesses vulnerabilities to detect, respond to, and prevent cyber incidents. Deployed worldwide, CyberMDX is designed to integrate with our customers’ existing environments through its scalable, easy-to-deploy and agentless solution.