Boston Scientific

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…

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…

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…

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…

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…

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…

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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