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Fast Five: Analysts expect rapid adoption of Boston Scientific’s Farapulse, Medtronic ICDs can help prevent sudden cardiac death

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, August 29, 2023.

Fast Five by MassDevice · Rapid adoption expected of Boston Scientific’s Farapulse, Medtronic ICDs have life-saving potential

SmileDirectClub and Align Technology are in a legal proceeding from a previous partnership. Fast Five hosts Sean Whooley and Danielle Kirsh discuss SDC’s plans to appeal a court order that said it has to pay Align Technology $63 million. In today’s episode, find out more about the proceeding and the SmileDirectClub’s appeal.

GE Healthcare has unveiled its latest wireless, handheld ultrasound device. Whooley explains what the device does, how accompanying digital tools help clinicians and what executives think about this unveiling.

Diabetes news and continuous glucose monitors continue to innovate. This…

Navigating the future of cell therapies with bit.bio exec Kathryn Corzo

Kathryn Corzo is currently the president and chief operating officer of bit.bio. The Cambridge, UK–based synthetic biology company specializes in providing human cells for research, drug discovery and cell therapy.

Her previous roles include a stint as the head of development for oncology cell therapies at Takeda. She also led the North American Innovation Center and R&D Digital Accelerator at Sanofi and held a leadership role in Lilly’s oncology business unit.

Bit.bio’s differentiated approach

Corzo’s decision to join bit.bio was rooted in the company’s pioneering approach to cell therapy. “Joining bit.bio became a clear choice,” she recalls. “The platform technology at bit.bio offers a solution to some of the significant challenges in the cell therapy field, mainly by manufacturing consistent cells at scale, speed and reduced costs thus democratizing access to human cells.…

Medtech Big 100 analysis: Sales grow, jobs decrease, R&D spending climbs

Our ranking of the world’s largest medical device companies shows record-high revenue and a double-digit boost in R&D activities.

Total sales are up but employment is down in our latest Medtech Big 100 ranking of the world’s largest medical device companies.

Aggregate revenue for the 2023 Medtech Big 100 grew 2.8% to a record-high $453.2 billion, the second straight year of growth after a rare dip in the first year of the COVID-19 pandemic.

More than three-quarters of the companies reported positive sales growth year-over-year, but the industry is still working to return to the type of growth rates it saw before the pandemic.

It’s worth noting that the aggregate revenue comparison year over year with the Big 100 is not perfect. The companies included on the list can vary a bit each year. However, the results were also positive when we compared the performance of the Medtech Big 100 companies in 2022 and early 2023 with their prior-year results, excl…

Orthofix launches new spine surgery navigation system

The 7D Flash navigation system. [Image courtesy of Orthofix]Orthofix Medical (Nasdaq: OFIX) + today announced the full U.S. commercial launch for its 7D Flash navigation system percutaneous module 2.0.

The company also confirmed the completion of the first cases in the U.S. with the module. It provides new planning features and increased functionality for the 7D Flash navigation system for minimally invasive spine surgery. The 7D system came from 7D Surgical, acquired by SeaSpine in 2021, after Orthofix and SeaSpine completed a merger this year.

7D Flash uses visible light to create a three-dimensional image for surgical navigation within seconds. This enables faster and more efficient spinal procedures, according to Orthofix. The company says it’s the only image guidance system that utilizes novel and proprietary camera-based technology coupled with machine-vision algorithms.

Orthofix said 7D Flash eliminate…

Dexcom appoints a new board director

New Dexcom board director Rimma Driscoll. [Image from Zoetis]Dexcom (Nasdaq: DXCM) + announced today that it appointed Rimma Driscoll to its board of directors.

The San Diego-based continuous glucose monitor (CGM) maker made Driscoll’s appointment effective on Aug. 24. She currently serves as EVP and head of global strategy, commercial and business development and global biodevices for Zoetis.

At Zoetis, a leading animal health company and a Fortune 500 member, Driscoll oversees the global business strategy. She manages the execution of commercial launch plans, external business development and integration efforts.

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

3M is reportedly close to reaching an earplugs lawsuit settlement

3M (NYSE: MMM) + is nearing a settlement with attorneys representing hundreds of thousands of veterans who say the company’s earplugs failed to protect them from hearing loss, according to media reports citing people close to the discussions.

Bloomberg News and The Wall Street Journal say the manufacturing giant would pay $5.5 billion under the tentative deal. Experts had previously suggested that 3M could end up paying much more if all the cases went to trial.

The news comes more than two months after a federal judge in Indianapolis rejected 3M subsidiary Aearo Technologies’ Chapter 11 bankruptcy filing. 3M had sought to use the bankruptcy as a strategy to shield itself from some liability and reach a deal with plaintiffs’ lawyers, but U.S. Bankruptcy Judge Jeffrey Graham said 3M’s financial support of the subsidiary meant that it was too early to seek protection.

Meanwhile, 3M continue…

Insulet fully launches Omnipod 5 in Germany, expects full European availability by end of 2024

Insulet’s Omnipod 5 with the Dexcom G6 CGM. [Image from Insulet]Insulet (Nasdaq: PODD) + announced today that it commercially launched its Omnipod 5 automated insulin delivery system in Germany.

Acton, Massachusetts-based Insulet released the device for individuals aged two years and older with type 1 diabetes. Germany marks the third market for the latest-generation patch pump. The company launched Omnipod 5 in the U.S. in August 2022, then began its launch in the UK in June of this year. It received CE mark approval for children aged two and up in September 2022.

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

Study: Medtronic ICDs can help prevent sudden cardiac death

The Aurora EV-ICD with the lead. [Image courtesy of Medtronic]Medtronic (NYSE: MDT) + today announced data demonstrating improved outcomes with its implantable cardioverter defibrillators (ICDs).

ICDs treat dangerously fast or irregular heart rhythms — ventricular tachycardia or ventricular fibrillation — that can lead to sudden cardiac death (SCD).

Two analyses demonstrated survival benefits nad a reduction in life-threatening cardiac events with the use of ICDs. Data provided real-world evidence supporting the use of Medtronic ICDs for indicated patients. Dr. Angelo Auricchio presented the results at the European Society of Cardiology (ESC) Congress in Amsterdam. Auricchio, the lead author of both analyses, serves as deputy head of cardiology and director of the clinical electrophysiology unit at Fondazione Cardiocentro Ticino in Lugano, Switzerland.

One retrospective analysis demonstrated an association of ICDs …

Abbott study shows OCT intravascular imaging improves stent procedure outcomes

The Ultreon 1.0 OCT platform. [Image courtesy of Abbott]Abbott (NYSE: ABT) + announced late-breaking data supporting the use of optical coherence tomography (OCT) imaging.

The ILUMIEN IV OPTIMAL PCI study evaluated the use of OCT during percutaneous coronary interventions (PCI). OCT imaging offers additional high-definition images that improve the visualization of vessel structure. This provides doctors with actionable data that translate into patient benefits, potentially shifting future approaches.

Abbott’s Ultreon OCT software, powered by AI, guides stents for precision placement. It provides enhanced views of coronary anatomy and blockages, supporting physician decision-making in real-time.

Compared to angiography, the study showed that this method helps improve stent expansion for a greater minimal stent area (MSA). Abbott says OCT guidance during PCI is associated with a lower risk of stent thrombosis (…

Boston Scientific stock rises on positive Farapulse results — analysts expect FDA approval, rapid adoption

Part of the Farapulse pulsed-field ablation system, the Farawave single-shot catheter is designed to create durable and circumferential lesions. [Image courtesy of Boston Scientific]Boston Scientific (NYSE: BSX) + announced positive 12-month results from the trial of its Farapulse pulsed-field ablation (PFA) system.

Shares of BSX rose 5.4% at $53.50 apiece in early-morning trading today. MassDevice’s MedTech 100, — which includes stocks of the world’s largest medical device companies — rose nearly 1%.

The pivotal ADVENT trial evaluated the nonthermal treatment for ablating heart tissue in patients with AFib. It marks the first randomized clinical trial directly comparing the efficacy and safety of Farapulse against standard-of-care ablation — either radiofrequency or cryoablation — for treating paroxysmal or intermittent AFib.

Boston Scientific presented findings at the annual meeting of the European So…

Philips says extended ECG Holter monitoring can improve diagnostic results

The ePatch extended-wear Holter ECG monitor. [Image from Philips]Philips (NYSE: PHG) + today shared data supporting the use of its extended-wear Holter electrocardiography (ECG) monitor.

The Amsterdam-based company presented the findings at the European Society of Cardiology Congress in Amsterdam. Results showed how specific diagnostic referral codes can potentially help to pre-determine how long a cardiology patient should receive mobile telemetry, or Holter monitoring, to monitor their symptoms remotely and possibly prevent further hospitalization.

Conventional Holter monitoring, analysis and reporting often prove labor-intensive and inefficient with potential high costs. The inconvenient process can include long turnaround times and negatively affected patient compliance and satisfaction. Philips designed its extended-wear Holter monitor, the ePatch, for several days of continuous monitoring.

Philips acquired eP…

Anebulo wins positive FDA feedback to Advance phase 3 program for cannabis

[Lifeking/Adobe Stock]

The clinical stage biopharma Anebulo Pharmaceuticals recently shared that it received positive FDA feedback after a Type B meeting in July, where the regulatory agency indicated a path to approval for ANEB-001, a competitive CB1 antagonist with a high affinity for the human CB1 receptor. Overstimulation of this receptor by cannabinoids such as THC causes the psychoactive effects of cannabis. ANEB-001 seeks to counter these effects in acute cannabinoid intoxication (ACI) by inhibiting the receptor’s activation.

The FDA indicated that a study of the cannabinoid antagonist ANEB-001 in ACI patients presenting to emergency departments together with a larger THC challenge study could support a new drug application.

ANEB-001 is Anebulo’s lead product candidate.

The company recently wrapped up an open-label part C extension of its phase 2 clinical trial to investigate ANE…