Boston Scientific Archives - Page 16 of 19

FDA approves Boston Scientific Vercise Genus deep brain stimulation system

Boston Scientific (NYSE:BSX) announced today that it received FDA approval for its fourth-generation Vercise Genus DBS system.

Marlborough, Mass.-based Boston Scientific’s Vercise Genus deep brain stimulation (DBS) system portfolio is approved for conditional use in a magnetic resonance imaging (MRI) environment. It features a family of Bluetooth-enabled, rechargeable and non-rechargeable implantable pulse generators capable of powering Cartesia directional leads to offer symptom relief for those suffering from Parkinson’s disease, according to a news release.

The fourth generation of the platform, Vercise Genus features increased battery life and improved directionality and stimulation capabilities as the Brainlab platform offers enhanced visualization capabilities for physicians to see lead placement within the context of each patient’s segmented target anatomy.

Vercise Genus is indicated for use in the bilateral stimulation of the su…

Boston Scientific to acquire Preventice Solutions

Boston Scientific (NYSE:BSX) announced today that it entered into a definitive agreement to acquire Preventice Solutions.

Minneapolis-based Preventice designs mobile health solutions and remote monitoring services for patients with cardiac arrhythmias. Its wearables include the PatientCare platform and BodyGuardian family of monitors.

Preventice’s BodyGuardian monitors use a fully-integrated, cloud-based platform for clinical technicians and AI algorithms to provide insights leading to improved clinical diagnoses and outcomes. The company’s BodyGuardian Mini Plus, the newest system in its portfolio, features multiple electrode options to enhance rhythm detection while it is also waterproof, repositionable and can be used in all modalities of short-term and long-term monitoring.

Marlborough, Mass.-based Boston Scientific’s acquisition of the company includes an upfront cash payment of $925 million with an additional $300 million availabl…

MedTech 100 roundup: Finally a dip as industry stays relatively strong

After three consecutive weeks of record-breaking numbers, medtech industry stocks finally fell backward over the past seven days.

MassDevice‘s MedTech 100 index finished last week at 105.8 (Jan. 15), marking a -0.95% drop from the 106.81 points (the highest ever total for the index) registered at the end of the week prior (Jan. 8). Medtech’s stock performance appeared to mirror overall markets as the S&P 500 Index saw a -1.5% loss, while the Dow Jones Industrial Average fared almost identically to medtech, falling by -0.91%.

The index still remains more than 13 points ahead of its pre-pandemic high of 92.32 on Feb. 19, 2020. Medtech’s lowest point during the COVID-19 pandemic remains at 62.13 on March 23. Since then, the industry’s stocks have experienced 70.3% growth in total, as of the end of last week. (Here are some of the best-performing medtech stocks from 2020.)

The industry continues to plug along and businesses continue to operate thro…

Boston Scientific launches WaveWriter Alpha spinal cord stim

Boston Scientific (NYSE:BSX) today said it launched its WaveWriter Alpha spinal cord stimulator systems in the U.S.

The systems are designed to deliver paresthesia-free pain relief in minutes. They are designed with Boston Scientific’s Fast-Acting Sub-perception Therapy (FAST) and have four MRI conditional, Bluetooth-enabled, rechargeable and non-rechargeable implantable pulse generators.

“We have found that the specific targeting and stimulation parameters of FAST uniquely engage the surround inhibition mechanism to produce rapid and robust pain relief,” Warren Grill, Duke University biomedical engineering professor, said in a news release. “What sets FAST apart from other forms of SCS is that we understand the underlying mechanism, which helps define clinical practices to optimize patient outcomes.”

WaveWriter Alpha systems are supported by Cognita Solutions to help address common challenges in pain management while raisin…

Boston Scientific’s preliminary Q4 results show 6.8% revenue decline

Boston Scientific (NYSE:BSX) announced today that its fourth-quarter net sales represent an approximate decline of 6.8% year-over-year.

Marlborough, Mass.-based Boston Scientific’s estimation of $2.71 billion in fourth-quarter revenue brings its full-year 2020 sales total to approximately $9.91 billion, marking a 7.7% total decline from 2019.

Wall Street analysts on average had predicted $2.86 billion in revenue in Q4.

The company highlighted that, within its organic results (which saw a fourth-quarter revenue decline of 8% year-over-year), it there was a negative impact associated with the conversion of U.S.-based Watchman customers to a consignment inventory model and the transition to the next-generation Watchman FLX left atrial appendage closure device, according to a news release.

Despite the negative impact made by the transition, both Boston Scientific and analysts are bullish on the future of Watchman, with CEO Mike Mahoney offering …

BREAKING: Big medtech suspends political contributions in wake of Electoral College vote

[Image from Unsplash]Just as they lined up to condemn last week’s attack on the U.S. Capitol, major medtech companies are suspending political contributions.

Boston Scientific announced on Sunday that it has chosen to temporarily suspend its political action committee (PAC) activity and “review our approach to future contributions.

“As we shared last week, we believe in respecting the integrity of the democratic process, the election outcome and the peaceful transition of power,” the company said in an email to MassDevice‘s sister site Medical Design & Outsourcing. “We remain committed to our values — including diversity and caring — in our work to bring meaningful medical innovations to physicians and patients who need them.”

By mid-afternoon today, Medtronic had taken a similar course, according to spokesman Ben Petok.

Get the full story on our sister site, Medical Design & Outsourcing.

MedTech 100 roundup: Ringing in the New Year with another high

For the third time in the past four weeks, stocks within the medtech industry climbed to never-before-seen heights as 2021 reared its head.

Previous highs have largely been a result of the FDA granting Moderna emergency use authorization for its vaccine candidate and its subsequent rollout to the U.S., joining the one made by Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX), which began to be administered last month.

With the industry plugging along, MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week at 104.67 (Jan. 1), marking its highest-ever total and a 1% uptick from the 103.63 points registered at the end of the week prior (Dec. 25, 2020).

A slight downturn came after the index hit a new high (100.75) on Dec. 4, 2020, beating the mark of 100.65 set on Nov. 9 and setting a new all-time high since the index started being recorded on Jan. 1, 2001. However, stocks have continued to rise …

Ambu, Boston Sci execs see domination for single-use scopes

Hospital closures connected to COVID-19 have cut into the sales of many medical device companies, but executives at rival makers of single-use scopes say pandemic has only heightened existing concerns about contamination, exposure and cost.

In interviews in this week’s DeviceTalks Weekly Podcast, executives from Ambu A/S and Boston Scientific (NYSE:BSX) said improved technology make single-use scopes as effective as reusable scopes without carrying the price tag or risk of infection traditional scopes require.

Steve Block, president of Ambu US, projected that over the next decade disposable scopes will account for a majority of devices sold, saying they’ll perform better than traditional devices, cost less, and eliminate the risk of infection. “There is just no reason to use a reusable product,” he said. He said Ambu has sold single-use scopes into 96% of the Top 500 hospitals in the US performing bronchoscopies.

Block appeared on the podcast alongside…

Which TAVR device is the best? It depends, researchers say

Edwards Lifesciences’ Sapien 3 Ultra TAVR [Image courtesy of Edwards Lifesciences]

Researchers published a paper in the Journal of the American Medical Association citing insufficient evidence regarding the superiority of TAVR devices.

Currently, only three TAVR devices are commercially available in the U.S., belonging to Edwards Lifesciences (NYSE:EW), Medtronic (NYSE:MDT) and Boston Scientific (NYSE:BSX), although several others are being used in clinical trials to evaluate safety and efficacy.

Get the full story at our sister site, Medical Design & Outsourcing.

Boston Scientific launches Vercise Genus DBS system in Europe

The Vercise Genus DBS system (Image from Boston Scientific)

Boston Scientific (NYSE:BSX) announced that it received CE Mark for its fourth-generation Vercise Genus deep brian stimulation system.

Vercise Genus includes full-body MRI conditional and Bluetooth capabilities within a DBS system designed for treating the symptoms of Parkinson’s disease, essential tremor and dystonia by delivering electrical stimulation to targeted parts of the brain.

Marlborough, Mass.-based Boston Scientific, which is rolling out the system in a limited European release as a result of regulatory approval, said in a news release that Vercise Genus adds features for patients such as a low-profile two-in-one extension with an option for abdominal placement, plus new software optimizes programming with imaging via an exclusive relationship with Brainlab.

European indication for the system includes use in unilater…

Boston Scientific stent gains added Medicare coverage

Boston Scientific (NYSE:BSX) announced today that CMS granted a new technology add-on payment (NTAP) for its Eluvia system.

Marlborough, Mass.-based Boston Scientific’s Eluvia drug-eluting vascular stent system received the NTAP as part of the 2021 inpatient prospective payment system (IPPS). The NTAP will be made effective on Oct. 1, 2020, to provide eligible hospitals with incremental reimbursement for Eluvia for up to three years, according to a news release.

Eluvia treats peripheral artery disease (PAD) by reopening the blocked artery and restoring blood flow while also utilizing a drug-polymer combination to offer a sustained, low-dose drug release to prevent tissue regrowth within the stented artery.

“The CMS determination is a very positive development for patients with PAD and supports what we have confirmed through our clinical trials – the Eluvia stent offers clinically superior outcomes compared to other peripheral drug-coated tech…

MedTech 100 roundup: Industry reaches new heights again

The past month has seen a resurgence from medtech companies in the markets and last week saw the best performance yet.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 90.78 points at the end of last week (Aug. 28). Overall, medtech stocks saw a 1.3% increase from the 89.6-point total at the same time a week prior (Aug. 21).

While 90.78 points is already the highest total on which the index has ended a week during the COVID-19 pandemic, just the day before, the index hit 91 points even, marking the highest point total since the pandemic took its toll.

The most recent high mark represents just a -1.4% dip from the Feb. 19 high point of 92.32, while the tally at the end of the week marks a -1.7% decrease from that pre-pandemic high.

Meanwhile, the S&P 500 Index saw a 3.3% increase from Aug. 14 to Aug. 21, having steadily climbed since reaching record highs on Aug. 18. Meanwhile, the …