Boston Scientific warns on some Vercise Genus implantable pulse generators

The Vercise Genus DBS system [Image from Boston Scientific]Boston Scientific (NYSE: BSX) + recently issued an urgent field safety notice for certain Vercise Genus deep brain stimulation (DBS) implantable pulse generators.

In the urgent field safety notice released in the United Kingdom, the company warned about the potential for Vercise Genus DBS IPG stimulation therapy to be transiently suspended during charging due to a device reset. Boston Scientific said the reset behavior occurs in response to the presence of potential interference during IPG charging. The IPG reset behavior is random and remote. Patients with devices exhibiting this reset behavior may not report any discernible impact.

Boston Scientific received reports of undesired sensation and/or transient worsening of movement disorder symptoms secondary to a transient loss of stimulation during IPG charging for patients with rechargeable DBS IPGs. Upon investig…

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Boston Scientific stock is up as Farapulse drives Q1 beat, raised guidance

Boston Scientific (NYSE: BSX) + shares got a boost this morning on first-quarter results that came in ahead of the consensus forecast.

Shares of Boston Scientific ticked up nearly 7% to $73.66 apiece in early-morning trading today. They got as high as $74.39 during the day, marking a 52-week best for the company. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose slightly.

The Marlborough, Massachusetts-based company reported profits of $495 million. That equals 33¢ per share on sales of $3.86 billion for the quarter ended March 31, 2024.

Boston Scientific recorded a 65% bottom-line gain on a sales increase of 13.8%.

Adjusted to exclude one-time items, earnings per share came in at 56¢. That landed 5¢ ahead of expectations on Wall Street. Sales also beat The Street as experts projected…

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Boston Scientific has positive Agent DCB study results

The Agent drug-coated balloon. [Image from Boston Scientific]Boston Scientific (NYSE: BSX) + reported positive investigational device exemption (IDE) trial data for its Agent drug-coated balloon (DCB).

The DCB just this month won FDA approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented vessel. Agent serves as an alternative to traditional therapies like balloon angioplasty, additional layers of stenting or radiation. The paclitaxel-coated balloon transfers a therapeutic dose of drug to the vessel wall, helping to prevent ISR reoccurrence.

The FDA approved the device, which received breakthrough designation in 2021, thanks to results from the FDA IDE trial. Data presented at TCT 2023 demonstrated statistical superiority for Agent compared to uncoated balloon angioplasty. Boston Scientific set a primary endpoin…

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FTC reportedly may scrutinize Boston Scientific’s Axonics deal

Bloomberg reports that the U.S. Federal Trade Commission (FTC) may look into the $3.7 billion acquisition of Axonics (Nasdaq:AXNX) by Boston Scientific (NYSE: BSX) + .

In January, Boston Scientific announced its plans to buy Axonics and its neuromodulation and hydrogel technologies. The companies said at the time that they expected the deal to close in the first half of this year.

Irvine, California-based Axonics develops neuromodulation systems for treating urinary and bowel dysfunction. The technology delivers mild electrical pulses to the sacral nerve, restoring communication between the brain and the bladder. The company also offers the Bulkamid urethral bulking agent for stress urinary incontinence symptoms.

According to the report, the scrutiny may arrive due to the companies’ shares of the urinary incontinence market. Bloomberg Intelligence Analyst Jennifer Rie claimed in the report that Boston Scien…

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FDA approves Boston Scientific’s Agent drug-coated balloon

The Agent drug-coated balloon. [Image from Boston Scientific]Boston Scientific  (NYSE: BSX) + announced today that it received FDA approval for its Agent drug-coated balloon (DCB).

The DCB won approval for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR occurs when plaque or scar tissue obstructs or narrows a stented vessel.

Marlborough, Massachusetts-based Boston Scientific plans a U.S. launch for Agent in the coming months. It already has availability in Europe, parts of Asia Pacific and Latin America. The system treats patients with ISR and previously untreated small vessel coronary disease.

Agent serves as an alternative to traditional therapies like balloon angioplasty, additional layers of stenting or radiation. The paclitaxel-coated balloon transfers a therapeutic dose of drug to the vessel wall, helping to prevent ISR reoccurrence.

The FDA approved the device,…

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Boston Scientific prices €2B offering to finance Axonics buy

Boston Scientific (NYSE: BSX) + announced that it priced an offering worth nearly $2.2 billion (€2 billion) in senior notes.

American Medical Systems Europe B.V., Boston Scientific’s wholly-owned finance subsidiary, priced the public offering. It includes €750,000,000 aggregate principal amount of 3.375% notes due in 2029 and €1,250,000,000 aggregate principal amount of 3.500% notes due in 2032. Notes will be fully and unconditionally guaranteed by the company.

The company intends to put the net proceeds toward its $3.7 billion acquisition of Axonics Modulation Technologies. Boston Scientific plans to add the funds to borrowings under its commercial paper program and cash on hand in financing the deal.

Axonics develops neuromodulation systems for treating urinary and bowel dysfunction. Its fourth-generation R20 rechargeable sacral neuromodulation (SNM) system received FDA approval around a year ago. Axonic…

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How GLP-1s tanked and reshaped the medtech stock market in 2023

Analysts weigh in on how the GLP-1 craze caused one of the biggest swings in the medtech stock market in recent years.

[Image courtesy of Nick Chong on Unsplash]In a tumultuous year for the medtech industry, promising clinical trial results on glucagon-like peptide 1 agonists (GLP-1s) created a seismic shift in the medtech stock market, triggering one of the largest dips in market value that analysts have seen in years.

While analysts said the medtech stock market performed well in 2023 – driven by strong market growth from the backlog of procedures that built up during the pandemic and more innovation and new product launches from companies – the fear of GLP-1s prevailed among investors, sending medtech stocks down significantly in the second half of the year, even as top executives sought to allay concerns.

The specter of GLP-1s such as Novo Nordisk’s Wegovy and Ozempic loomed large, casting doubt on medtech’s future trajectory at the end of the year. However, the stocks have almost fully recovered since then. Analysts predict a rebound in 2024, with diminishing head…

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Boston Scientific completes first commercial Farapulse cases in U.S.

The Farapulse system in full with the Farawave ablation catheter, Farastar ablation generator and Faradrive steerable sheath. [Image courtesy of Boston Scientific]Boston Scientific (NYSE: BSX) + has completed the first post-FDA approval cases in the U.S. with its Farapulse pulsed field ablation system.

In a LinkedIn post, Nick Spadea-Anello, president, Electrophysiology, Boston Scientific, announced the first commercial use for the AFib treatment. Marlborough, Massachusetts-based Boston Scientific won the approval for Farapulse last month.

In doing so, it became second company to earn an FDA nod for PFA that treats AFib. Medtronic picked up the first approval for PFA to treat paroxysmal and persistent AFib in December. Approval allows the use of Farapulse in the isolation of pulmonary veins to treat drug-refractory, recurrent, symptomatic, paroxysmal AFib.

Chief Medical Officer Dr. Ken S…

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FDA expands approval for Boston Scientific spinal cord stim to include chronic back pain

The WaveWriter Alpha spinal cord stimulator systems [Image courtesy of Boston Scientific]Boston Scientific (NYSE: BSX) + announced today that the FDA approved an expanded indication for its WaveWriter spinal cord stimulation (SCS) systems.

The indication covers chronic low back and leg pain in people without prior back surgery — called non-surgical back pain (NSBP).

Boston Scientific says first-line treatment for people with chronic back pain tends to have limitations. Conventional medical management like physical therapy and medication tend to prove less effective for many people. Effective chronic pain management may lead to improved quality of life and reduced opioid use.

In a news release, Dr. James North of the Carolinas Pain Institute said this expanded indication helps people with limited treatment options. North also served as the principal investigator for the SOLIS trial of the technology for treating NSB…

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What’s next for Boston Scientific after Farapulse’s FDA approval?

The Farapulse system in full with the Farawave ablation catheter, Farastar ablation generator and Faradrive steerable sheath. [Image courtesy of Boston Scientific] Chief Medical Officer Dr. Ken Stein explains the plans at Boston Scientific after its landmark pulsed field ablation approval

On Jan. 31, Boston Scientific (NYSE: BSX) + became the second company to receive FDA approval for a pulsed field ablation (PFA) system that treats AFib.

The landmark approval came just over a month after Medtronic became the first company to win an FDA nod for PFA to treat paroxysmal and persistent AFib in December.

Pulsed field ablation has generated a great deal of excitement in the medical device industry. Its potential advantages versus radiofrequency ablation or cryoablation include the characteristic that heart muscle tissue can be especially susceptible to it, while other types of surrounding tissue are injury-resistant.

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Boston Scientific picks new investor relations VP, chief accounting officer

Boston Scientific (NYSE: BSX) + announced that it appointed a new SVP of investor relations and a new chief accounting officer.

In an SEC filing, the company announced the appointments, made on Jan. 26. Jonathan Monson takes over as SVP, investor relations, effective March 1, 2024. Monson currently serves as SVP, global controller and chief accounting officer, positions he took up in July 2019.

With Monson departing those roles, Boston Scientific chose Emily Woodworth as SVP, global controller and chief accounting officer. Woodworth takes over on March 1 as well. She currently serves as VP of finance and controller of the company’s Urology unit, having also taken on those posts in July 2019.

Before her current role, Woodworth was director of global technical accounting and external reporting from April 2016 until July 2019. Prior to that, she served as controller and finance director for Boston Scientific&…

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FDA approves Farapulse pulsed field ablation tech from Boston Scientific

The Farapulse pulsed field ablation system. [Image courtesy of Boston Scientific]Boston Scientific (NYSE: BSX) + announced today that it received FDA approval for its Farapulse pulsed field ablation (PFA) system.

Shares of BSX ticked up 4.2% at $64 apiece in pre-market trading on the back of the news, as the company also posted strong fourth-quarter earnings results.

The much-anticipated approval makes Boston Scientific the second company to earn an FDA nod for PFA that treats AFib. Approval enables the use of Farapulse in the isolation of pulmonary veins to treat drug-refractory, recurrent, symptomatic, paroxysmal AFib.

Medtronic became the first company to win an FDA nod for PFA to treat paroxysmal and persistent AFib in December.

“The approval of the Farapulse PFA system marks an important milestone for the millions of people living with paroxysmal AF and is an incredible opportunity to bring the fi…

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