Boston Scientific touts data from Phase 3 study of selective internal radiation therapy

Boston Scientific (NYSE:BSX) today touted data from a Phase 3 clinical trial of its TheraSphere Y-90 glass microspheres treatment.

In the trial, the TheraSphere treatment successfully met both primary endpoints, including progression-free survival (PFS) and hepatic progression-free survival (hPFS) in patients with metastatic colorectal cancer (mCRC) of the liver.

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

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Boston Scientific completes $1.1B Lumenis acquisition

Boston Scientific (NYSE:BSX) announced today that it completed the nearly $1.1 billion acquisition of the global surgical business of Lumenis.

Marlborough, Massachusetts-based Boston Scientific announced in March that it entered into a definitive agreement with an affiliate of Baring Private Equity Asia (BPEA) to acquire Lumenis’ surgical business, which develops and commercializes energy-based medical solutions. The deal includes an upfront cash payment of $1.07 billion, subject to closing adjustments, according to that previous announcement.

In a news release, Boston Scientific said that Lumenis’ surgical business, which includes premier laser systems, fibers and accessories for urology and otolaryngology procedures, expects to bring in revenues around approximately $200 million across 2021.

The two companies have held a relationship for over 20 years, with Boston Scientific already offering the Lumenis urology laser portfolio in the U.S. a…

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Abbott touts Amplatzer Amulet results in head-to-head trial with Boston Scientific’s Watchman

Abbott (NYSE:ABT) touted its Amplatzer Amulet device as superior according to results from a head-to-head trial with Boston Scientific’s (NYSE:BSX) Watchman.

Late-breaking data presented at European Society of Cardiology Congress and simultaneously published in Circulation support the recent approval for the Amplatzer Amulet granted by the FDA, Abbott said in a news release. The Amplatzer Amulet LAA occluder is comprised of a small pouch that connects to the upper left chamber of the heart in an effort to reduce ischemic stroke risk for people with atrial fibrillation (AFib).

Results presented show that the Amplatzer Amulet left atrial appendage (LAA) occluder was superior for the primary endpoint of LAA closure and non-inferior for the primary endpoints of safety and effectiveness when compared to Boston Scientific’s Watchman.

The Amplatzer Amulet LAA occluder is comprised of a small pouch that connects to the upper left chamber of the heart in an…

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MedTech 100 roundup: Industry reaches another high point

The medtech industry is continuing its massive 2021 boom, with the past week marking yet another record in the markets.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (Aug. 27) at 121.05 points, representing a 1.2% rise from the 119.63-point mark set a week before. Following a slight dip earlier this month, the industry continues to tick up to new heights.

Medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry remains well above the marks set around the height of the pandemic, having registered a 31.1% increase from the pre-pandemic high of 92.32 (set on Feb. 19, 2020). Moreover, it remains well ahead of the mid-pandemic low of 62.13 (March 23, 2020) as well, totaling a 94.8% ascent above that point.

The industry’s performance fell in line with the overall markets this past week as the S&P 500 I…

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SVB Leerink analysts expect Abbott to gain share on Boston Scientific’s Watchman

Analysts believe Abbott (NYSE:ABT) may gain traction on Boston Scientific’s (NYSE:BSX) Watchman in the left atrial appendage closure (LAAC) space.

The second LAAC survey commissioned by SVB Leerink, which compared information from electrophysiologists to information from interventional cardiologists in the previous survey, pointed to the deceleration of Watchman volume expectations from double-digit growth in 2021-2022 down to high-single-digit-growth in 2023, according to analysis.

Analysts say that, although Abbott’s gain of traction in the LAAC space — with the company garnering FDA approval for its Amplatzer Amulet device earlier this month — comes to a lesser extent than Boston Scientific’s, the survey points to faster volume growth at centers adopting both devices and better Boston Scientific market share retention overall.

The surveyed electrophysiologists projected Abbott’s share shift at 18% in 2023 (against 24% share pro…

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Boston Scientific touts future of its MedSurg segment

Boston Scientific executive Dave Pierce sees a bright future for the company’s GI endoscopy and urology technologies.

As many companies did, Boston Scientific (NYSE:BSX) had to adapt during the COVID-19 pandemic and, with the lessons learned, it may be better for it.

Dave Pierce, the executive VP of Boston Scientific’s MedSurg segment, certainly thinks so.

“Our team has really persevered and performed at a high level despite all the uncertainty of the past year,” Pierce told MassDevice following the release of the company’s second-quarter financial results. “We as a company are really proud of how we’ve worked to make a safe environment, give employees what they need from a mental health standpoint and help everyone navigate through the uncertainty of the pandemic.”

Year-over-year, Boston Scientific’s medsurg segment’s revenues grew by 64.6%. Those numbers were largely influenced by the fact tha…

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FDA clears Boston Scientific’s Exalt Model B single-use bronchoscope

[Image from Boston Scientific]Boston Scientific (NYSE:BSX) announced today that it received FDA 510(k) clearance for its Exalt Model B single-use bronchoscope.

Marlborough, Mass.-based Boston Scientific designed the Exalt Model B for use in bedside procedures within the intensive care unit and operating room, according to a news release. Uses for the device include a wide range of bronchoscopy procedures, including secretion management, airway intubation, percutaneous tracheostomy, double-lumen endotracheal tube placement and biopsies.

According to a news release, Boston Scientific offers the device in three sizes — slim, regular and large — with each sizing designed to offer superior suction performance and direct, precise imaging.

Exalt Model B joins the Exalt Model D single-use duodenoscope, the LithoVue digital flexible ureteroscope, the SpyGlass DS direct visualization system and the SpyGlass Discover digital catheter. Exalt Model B received CE mark ap…

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Boston Scientific has a serious recall involving tens of thousands of pacemakers

FDA has designated Boston Scientific’s recall of its Ingenio family of pacemakers as Class I, its most serious level.

The agency’s Class I designation for Ingenio, posted on Aug. 6, said the recall involves 48,000 devices — model Nos. J174, J177, K174, K184 and K187. The pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) in the recall include models such as the Advantio DR EL, Ingenio DR EL and Vitalio DR EL. The manufacturing dates are from September 2011 to December 2018, with distribution from November 1, 2011, to August 1, 2020.

Boston Scientific initiated the recall on June 3 because the pacemakers or cardiac resynchronization therapy pacemakers may incorrectly transition to safety mod. Going into safety mode could create a risk of inappropriate pacing loss due to sensing muscle contractions. Once the pacemaker goes into safety mode, it is not possible to reprogram it.

FDA said there have been 65 reported incidents rela…

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Boston Scientific initiates trial for EkoSonic endovascular system

[Image from Boston Scientific]Boston Scientific (NYSE:BSX) announced today that it began enrollment for a clinical trial of its EkoSonic endovascular system (EKOS).

Marlborough, Mass.-based Boston Scientific’s HI-PEITHO trial, a collaborative research study with the Pulmonary Embolism Response Team (PERT) Consortium and the University Medical Center of the Johannes Gutenberg University of Mainz, will compare EkoSonic in combination with anticoagulation to anticoagulation alone for treating acute, intermediate-high-risk pulmonary embolism (PE).

According to a news release, EKOS uses ultrasound energy in combination with the thrombolytic drug to dissolve blood clots and restore blood flow in patients with PE and peripheral arterial occlusions. EKOS’ ultrasound technology accelerates thrombolysis by minimizing the time it takes to treat a patient and lowering the necessary thrombolytic dose, which can lower the risk of bleeding.

The randomized HI-P…

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5 challenges Boston Scientific overcame to make single-use scopes work

FDA wanted single-use scopes to reduce potentially deadly superbug infections. Here’s how Boston Scientific made it happen. The Exalt Model D single-use duodenoscope [Image courtesy of Boston Scientific]Boston Scientific’s Exalt Model D Single-Use Duodenoscope received FDA clearance in December 2019. It was the first device of its kind to hit the medical market. Just five months earlier, the FDA urged device manufacturers to move away from re-usable duodenoscopes with endcaps that were more difficult to clean and led to “superbug” infections in 1 in 20 cases. As it so happened, Boston Scientific was already working on a single-use scope.

Now on the market, Exalt is making its way into physician’s offices, but it was a complicated journey.

Boston Scientific’s chief medical officer Dr. Brian Dunkin recently told our sister site Medical Design & Outsourcing that the company overcame five challenges to make Exalt a reality. Go to MDO to read more. 

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MedTech 100 roundup: Industry climbs with earnings season in full swing

The medtech industry remains on the upswing as companies see their stocks rising with quarterly earnings providing a boost.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (July 30) at 118.86 points. Two weeks ago aside — when the index shot up to 145.88 points and quickly tumbled down — this mark would be the index’s all-time best.

The total at the end of last week represents a 2.9% rise from the 115.54-point tally posted by the index at the end of last week (July 23).

Medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry has registered a 28.7% increase from the pre-pandemic high of 92.32 (set on Feb. 19, 2020). Moreover, it remains well ahead of the mid-pandemic low of 62.13 (March 23, 2020) as well, totaling a 91.3% ascent above that point.

The industry’s performance had no cor…

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Boston Scientific rises before hours on Street-beating Q2

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

The Marlborough, Mass.-based company posted profits of $172 million, or 12¢ per share, on sales of $3.1 billion for the three months ended June 30, 2021, marking a massive bottom-line gain from losses of $153 million this time last year on sales growth of 53.6%.

Adjusted to exclude one-time items, earnings per share were 40¢, 3¢ ahead of Wall Street, where analysts were looking for sales of $2.9 billion.

Each reportable segment saw significant growth year-over-year, with Boston Scientific’s rhythm and neuro business registering a 65% revenue increase, while medsurg grew by 64.6% and cardiovascular ticked up 51.4%.

“We delivered excellent results this quarter, with strong momentum throughout our portfolio and faster-than-market growth in most segments, fueled by our team’s dedication to customers and patients al…

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