HRS 2018 Roundup: Device-related blood clots with Boston Scientific’s Watchman implant

Data from a study of device-related blood clots and the Watchman cardiac implant made by Boston Scientific (NYSE:BSX), presented today at the annual meeting of the Heart Rhythm Society in Boston, indicate the need for aggressive management of patients at risk for device-related thrombosis.

There were 74 incidences of DRT in 65 of the 1,739 Watchman patients examined in the study, or 3.7%; eight of those patients had multiple DRTs and two experienced embolic events (0.45%). There was no significant difference in mortality between patients with DRT and those without, according to the study.

Lead author Dr. Vivek Reddy, of New York’s Mt. Sinai Hospital, told MassDevice.com that the overall incidence of DRT for Watchman in the study was 3.7% using the FDA-approved strategy for anti-coagulation drugs. The surprise, Reddy told us, was the high rate of ischemic stroke in the DRT population.

“It’s surprising, not from a patho-physiological conceptual perspective, but it’s surprising because when we looked at this very early in Protect AF, again a small number of the patients in a relatively small follow-up, we did see that the subsequent stroke rate was a little bit higher, but certainly nothing like this,” he said. “We knew it was important, we knew that you had to do surveillance, we knew that if you see it you need to treat it, but we didn’t expect it to be this high.

“I think what this tells me, is that one has to be aggressive about dealing with device-related thrombus,” Reddy said, noting that it’s less clear how to proceed over the long term than in acute cases.

“It’s pretty clear how you treat it acutely – you give anticoagulation and let it dissolve,” he explained. “What’s less clear, though, is what do you do long-term after that. I think that what I would recommend, not that we have definitive data on this yet, but what I would recommend is aggressive surveillance in those patients who had device-related thrombus. I would recommend that some of them will probably require longer-term anticoagulation. That’s my guess.

“These data I don’t think take away from the argument that Watchman is a reasonable strategy. It doesn’t add or detract from the previous data. What it does do though is, I think it hones in and says when you have this you have to treat those patients aggressively,” Reddy told us.

Next >>

The post HRS 2018 Roundup: Device-related blood clots with Boston Scientific’s Watchman implant appeared first on MassDevice.

Fitbit unveils array of new apps from health partners

Fitbit (NYSE:FIT) revealed today a suite of new apps and clock faces designed to help people manage their health, including a glucose monitoring app from Dexcom (NSDQ:DXCM) that is slated to launch in the second half of 2018.

The Las Vegas-based company also announced programming from Diplomat Pharmacy, Humana (NYSE:HUM), One Drop and Walgreens.

Get the full story at our sister site, Drug Delivery Business News.

The post Fitbit unveils array of new apps from health partners appeared first on MassDevice.

Google, Fitbit ink collab healthcare deal, look to challenge Apple Watch

Fitbit (NYSE:FIT) yesterday announced plans for a health-care collaboration with Google (NSDQ:GOOG), giving Apple (NSDQ:AAPL) and its Apple Watch more competition in the mobile health monitor market.

The wearable developer plans to use Google’s Cloud healthcare API for further healthcare system integration, which could allow FitBit activity data to be integrated with electronic medical records for more personalized care, Fitbit said.

“Over the past decade, we have built an incredible foundation as the leading wearables brand, helping millions of people around the world make lasting behavior changes that improve their health and wellness through fun and engaging experiences. Working with Google gives us an opportunity to transform how we scale our business, allowing us to reach more people around the world faster, while also enhancing the experience we offer to our users and the healthcare system. This collaboration will accelerate the pace of innovation to define the next generation of healthcare and wearables,” Fitbit co-founder & CEO James Park said in a prepared statement.

Both companies will also aim to improve management for chronic conditions, including diabetes and hypertension, through the use of services like Twine Health, which Fitbit recently acquired. Fitbit said that using the cloud platform will also allow it to scale more quickly and more properly protect user privacy.

“At Google, our vision is to transform the way health information is organized and made useful. By enabling Fitbit to connect and manage key health and fitness data using our Google Cloud Healthcare API, we are getting one step closer to this goal. Together, we have the opportunity to deliver up-to-date information to providers, enhancing their ability to follow and manage the health of their patients and guide their treatment,” Google Cloud healthcare VP Dr. Gregory Moore said in a press release.

Last month, the American Medical Association said it would partner with Google to launch the AMA Health Care Interoperability and Innovation Challenge designed to support mobile health technology that improves monitoring and care in the management of chronic diseases.

The post Google, Fitbit ink collab healthcare deal, look to challenge Apple Watch appeared first on MassDevice.

How the Apple Watch & other wearables could help highlight early signs of diabetes

  • Steve Maxson joins Fermatex as VP of marketing and sales

    Fermatex Vascular Technologies (formerly Gore-Jersey Shore and Adam Spence Corporation) recently announced that Steve Maxson has joined the company as VP of marketing and sales. “I’m very pleased to have Steve join the Fermatex team at this exciting time of transition and growth. His technical experience and commitment to responsive service will ensure that we remain […]

  • Nearly 90% of clinicians will use bedside mobile tech by 2022, study says

    A new study from Zebra Technologies reports that 9 out of 10 clinicians will use mobile technology at the bedside for acute care within the next four years. The company received feedback from 1,500 nursing managers, IT decision-makers and patients to determine how patient care will transform by 2022. The ability to use mobile devices […]

  • Trumpf touts newest laser technology at Photonics West

    Trumpf is touting its TruMicro 5370 and TruMicro 7380, Dira 200-5 and a TruLaser Station 5005 with a TruMicro 2030 laser system Photonics West in San Francisco, Calif. at booth #817. The company’s short and ultra-short pulsed TruMicro 5370 and 7380 lasers are designed for micro-processing. They are used in standard processing methods like cutting, drilling, […]

  • Dow touts versatility in latest LSR grades for overmolding

    Dow Medical Solutions, a business unit of the DowDuPont Specialty Products Division has introduced two new liquid silicone rubber (LSR) technologies to support a broader range of rigid plastic substrates for overmolding applications. These new elastomeric products give designers and manufacturers greater options for creating differentiated devices with improved safety and durability. The two grades include […]

  • Spectralytics launches DFM product development facility for laser services

    In the new medtech manufacturing environment, design engineers need parts faster, with fewer iterations and quicker turnaround. Spectralytics aims to meet those needs with its revamped development center in Maple Plain, Minn. The laser cutting and processing contract manufacturer has a newly expanded facility dedicated to design and prototyping. The 15,000 sq. ft. facility is located […]

  • Mack Molding systematizes ISO 9001 and 13485 revisions

    Mack Molding recently announced that is has started the process of systematizing ISO 9001:2015 and ISO 13485:2016 fifth and third revisions for medical devices. The company plans to train internal auditors to help assure that Mack Molding is ready to be certified after audits that are scheduled for July. “When we first implemented ISO 9001 […]

  • GW Plastics expands in-house tooling capabilities

    GW Plastics (Royalton, Vt.) recently announced that it has expanded and upgraded its tooling facility, adding additive manufacturing technology. The company has invested in medical 3D printing technology to help with conformal cooling and improve cycle times up to 30%. “This additive manufacturing technology streamlines tool design, reducing the components needed to build a mold […]

  • Raumedic investing in modernizing headquarters

    Raumedic (Helmbrechts, Germany) is investing 1 million Euros in expanding and modernizing its German headquarters. The company will add a state-of-the-art customer center while improving working conditions for employees. The company is adding a new foyer with additional meeting areas. The older buildings at the Helmbrechts-based headquarters will be the main areas undergoing modernization, which […]

  • Software is a top cause of medical device recalls: Here’s what you can do

    Stericycle Expert Solutions recently conducted a five-year assessment of recall trends, based on its quarterly Recall Index studies. The results show surprising missteps from medical device companies, especially where software is concerned. We asked Chris Harvey, director of recall solutions at Stericycle to answer some questions about the recall trends and offer some advice on […]

  • Report: Medical device recalls down in Q4 of 2017

    The medical device industry saw a 9% decline in recalls in the last quarter of 2017, the lowest quarter since the fourth quarter of 2011. Stericycle Expert Solutions reports in its annual Recall Index that one of the major causes of medical device recalls over the past five years is technological advances. Chris Harvey, director […]

  • Webinar: How a 3D printer’s versatility enables medical innovation

    Wednesday, Feb. 21, 2018 11:30am Eastern time / 8:30am Pacific time     View this webinar to learn how 3D printing’s versatility has paved the way for medical advancements by Cardiovascuar Systems. To help fight the battle against CAD and PAD, CSI works continuously to advance their devices and develop new innovations – work that […]

  • One Drop wants to help lead a healthcare revolution for people with diabetes – here’s how

    Share

    One DropWhen Jeff Dachis was diagnosed with Type I diabetes four years ago, he remembers leaving the doctor’s office with a sinking feeling in his chest.

    “I had about six minutes with a nurse practitioner and was given an insulin pen and a prescription and a pat on the back – and I was out the door,” he told Drug Delivery Business News. “I was concerned for my family, I was concerned for my kids. I didn’t really know what this was going to mean for me.”

    He found himself searching for devices or products to help him manage his diabetes. From counting carbohydrates to calculating insulin doses, diabetes is a data-driven disease.

    Get the full story at our sister site, Drug Delivery Business News.