Boston Scientific Archives - Page 13 of 19

MedTech 100 roundup: Return to normal following recent spike

After back-to-back all-time best performances, the medtech industry had a slight regression over the course of the last week.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — had been continuously ticking up since the beginning of April, with its mark of 112.25 on April 16 representing an all-time best, topping the previous high of 110.96 set on Feb. 15.

Just one week later, the index topped itself again, reaching 114.58 to end the week on April 23, marking an increase of 2.1% from the previous week. However, things have settled down and the industry responded in kind, dipping -1.6% to 112.7 to end last week (April 30).

In spite of the slight decrease over the past week, the industry continues to reflect a bounceback from the struggles brought on by the COVID-19 pandemic.

Overall, has produced a 22.1% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus an 81.4% increase from…

Boston Scientific, Stryker may get extension on Medicare payments

CMS has issued a proposal for the 2022 fiscal year that would potentially help big medtech companies like Boston Scientific and Stryker.

Released yesterday, the proposal for the Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) offers updated Medicare payment policies and rates for operating and capital-related costs of acute care hospitals and for certain hospitals and hospital units excluded from the IPPS for fiscal 2022.

CMS’ aim for the proposal is to close healthcare equity gaps and support greater access to certain diagnostics nad therapies during the ongoing public health emergency brought on by COVID-19 and beyond.

Within the proposal is a list of technologies that would receive an additional year of new technology add-on payments (NTAP), which includes devices from Boston Scientific and Stryker, among several other medtech companies.

Boston Scientific’s E…

Boston Scientific rises before hours on Street-beating Q1

Boston Scientific (NYSE:BSX) shares ticked up before hours today on first-quarter results that beat the consensus forecast.

The Marlborough, Mass.-based company posted profits of $327 million, or 23¢ per share, on sales of $2.8 billion for the three months ended March 31, 2021, for a massive bottom-line gain from profits of $11 million this time a year ago on sales growth of 8.2%.

Adjusted to exclude one-time items, earnings per share were 37¢, 6¢ ahead of Wall Street, where analysts were looking for sales of $2.6 billion.

Boston Scientific experienced year-over-year improvements across its segments, with medsurg registering 11.1% growth, its cardiovascular business achieving a 10% uptick and rhythm and neuro growing by 6.8%.

“We are pleased by the trajectory of our recovery,” Boston Scientific chairman & CEO Mike Mahoney said in a news release. “Our global team remains committed to helping patients and our customers by deliv…

DTW Podcast: Herrera on how military lessons led to Medtech career; Ulmer ready to redo landmark FDA survey

Derek Herrera and Kwame Ulmer are featured on this week’s DeviceTalks Weekly Podcast.

In this week’s podcast, Derek Herrera explains how a serious battle injury he received while leading Marines in Afghanistan led him to build a career in medtech.

Herrera has founded two companies – Spinal Singularity and Habit Camera – to create devices that can improve and save the lives of people who need help the most. Herrera also explains how his military training is serving him so well in medtech and how the medical device industry would benefit from including more veterans in its workforce.

We’ll also hear from Kwame Ulmer, principal at Ulmer Ventures and a lecturer at UCLA Anderson’s School of Management, about an effort his helping to lead to update the landmark study compiled by Josh Makower in 2010. The study blasted a regulatory process that it called “unpredictable, inefficient and expensive.”

Its finding led to introspection and changes, according to…

Boston Scientific touts results of Watchman study

Boston Scientific (NYSE:BSX) is touting 12-month results from a trial assessing its next-generation Watchman left atrial appendage closure (LAAC) device.

Results from the Pinnacle FLX trial were published in Circulation and highlighted the safety and efficacy of Watchman in stroke prevention for patients with non-valvular atrial fibrillation (NVAF).

The 400-patient study observed Watchman FLX as an alternative to oral anticoagulation therapy, which includes non-vitamin K oral anticoagulants. It met its primary safety endpoint of occurrence of a major procedure-related complication within seven days following the procedure, registering a low adverse event rate of 0.5%.

Additionally, the trial met its primary effectiveness endpoint as the data demonstrated a 100% rate of effective LAAC at 12 months post-procedure.

Implant success tallied a rate of 98.8% and no patients experienced peri-procedural death, device embolization …

4 innovative devices delivered through catheters

[Images from Boston Scientific, Abbott, Edwards Lifesciences and Medtronic]Physicians use catheters to deploy numerous life-saving devices across the healthcare realm, from cardiovascular to neurovascular.

They typically insert the thin, flexible tubes in a process called catheterization to deploy devices such as left ventricular assist devices (LVADs), transcatheter aortic valve replacements (TAVRs) and occluders to stop bleeding. The catheter industry is regularly innovating to keep up with the medtech industry’s growing demand for smaller devices for larger patient populations.

Throughout 2020, we saw a number of FDA clearances and approvals for catheter-based technologies, including ones designed for conditions renal denervation and heart failure. Just a few months into 2021, the FDA has approved catheter-based innovations by two major medtech companies. Two others developed for high-risk patients are worth revisiting.

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8 medical device companies that beat the COVID-19 pandemic and prospered

[Image from unsplash.com]Some medical device businesses not only survived the COVID-19 pandemic but actually thrived — with many producing the medtech needed to fight the coronavirus’s spread.

Medical Design & Outsourcing recently analyzed financials for 20 of the largest medical device businesses in the world. Not only was revenue only slightly down for the 20 during 2020, but it was actually up for eight of the 20 companies.

For many of the eight companies that saw sales increase, there was a common theme: They pivoted their focus to the diagnostics imaging and personal protective equipment needed to against COVID-19.

“We had different kinds of companies that were able to benefit on some level from COVID and shutdowns,” Richard Newitter, senior research analyst at SVB Leerink, told MDO.

Overall, medtech sales declined in Q1 and Q2 but then bounced back in a V-shaped recovery for the rest of the year, according to Newitter “It plateaued and actu…

MedTech 100 roundup: Slight rise for the industry

While medtech’s performance still isn’t mirroring the beginning of 2021, the industry is showing signs of life with a small improvement last week.

The year’s strong start, during which MassDevice‘s MedTech 100 index notched an all-time best of 110.96 points (Feb. 15) came to an end later that month and carried over into March, with the index hitting its lowest recent point on March 8 (102.16), marking a fall at a level not seen since October.

Even after a slight rise earlier this month, the index struggled again two weeks ago with another small dip. However, after coming in at 104.05 on March 19, the index got a slight boost over the past week, finishing at 104.87 on March 26, representing a 0.8% rise.

Despite the up-and-down nature of the past couple of months, the index represents a much better situation for the industry compared to this time a year ago when the COVID-19 pandemic was in full swing. The index is up 13.6% from its pre-p…

DTW Podcast – CEO MacMillan on how COVID-19 strengthened Hologic

Hologic CEO Steve MacMillan says in early March 2020 he didn’t appreciate how COVID-19 would change the world forever. But the diagnostics company quickly rose to the challenge, becoming one of the surer suppliers of diagnostic tests needed to chart the Coronavirus’ severity.

In this DeviceTalks Weekly Podcast, MacMillan shares how Hologic pivoted to meet the calls for help from political leaders in the US and around the world.

He also shares what’s next for the company which has shed its aesthetics business in favor of a tighter new course, a course that includes the creation of an innovative information index that will yield new data on women’s health.

While Hologic rose to the challenge during the pandemic, GuardianLane is ready to help children who are coping with grief, including the loss of loved ones to COVID-19 and other diseases.

CEO Kristina Jones shares the story that won the first pitch contest held by Medtech Color, an organization fo…

How big medtech fared during a year of COVID-19

[Image from Unsplash]Despite numerous challenges, the medtech industry showed itself to be fairly recession-proof in 2020, according to a Medical Design & Outsourcing/MassDevice analysis of financials.

Annual reports recently released by 20 of the world’s largest medical device companies showed only a slight dip in revenue during 2020 — a year in which medtech held the front lines against the COVID-19 pandemic. Employment was also up slightly amongst the top earners, while R&D spending held its own.

The 20 companies included in the MDO analysis include 3M Healthcare, Abbott (medical device segment), Alcon, Align Technology, Baxter, Boston Scientific, Danaher (life sciences and diagnostics segment), Dentsply Sirona, Edwards Lifesciences, GE Healthcare, Henry Schein, Intuitive Surgical, Johnson & Johnson (medical device segment), Medline Industries, Owens & Minor, Royal Philips, Smith+Nephew, Stryker, Teleflex and Zimmer Biomet.

Get the full s…

Federal judge won’t let Boston Sci avoid Watchman lawsuit

[Image from Unsplash]A federal judge in western North Carolina has declined to dismiss a wrongful death lawsuit against Boston Scientific (NYSE:BSX) over its Watchman stroke prevention device.

Boston Sci had sought to have the suit — brought by the Jean Penland estate — dismissed based on the Supreme Court’s decade-old Riegel v. Medtronic decision. The Riegel ruling found that federal medical device regulation laws provide lawsuit protections for devices with FDA premarket approval, and Watchman received a PMA in 2015.

However, Penland’s estate and its executor Donna Shook argued that their claims involve a clear and specific manufacturing and assembly defect. They want to hold Boston Sci’s medical device to the performance characteristics and functional principles presented to and approved by the FDA.

Penland died in 2018 after months of severe respiratory distress and injuries after a Watchman during implantation surgery embolized free of the …

Boston Sci settles host of state pelvic mesh lawsuits for nearly $189M

Boston Scientific (NYSE:BSX) has agreed to pay $188.6 million to 47 states and the District of Columbia to resolve claims that it deceptively marketed transvaginal surgical mesh devices, state AGs announced today.

Pelvic mesh products have been one of the medical device industry’s worst failures so far in the 21st century. First cleared nearly two decades ago, pelvic mesh products were meant to treat the weakening of the muscles and ligaments supporting a woman’s pelvic organs. But they became the subject of thousands of lawsuits and millions of dollars in settlements as women reported pain, excessive bleeding and loss of sexual function.

Boston Sci and Coloplast were the final two companies to sell the devices. FDA ordered a halt to pelvic mesh sales in 2019.

The multistate complaint against Boston Sci claimed that it failed to disclose the full range of potentially serious and irreversible complications caused by mesh. On top of paying the money,…