Boston Scientific Archives - Page 2 of 19

Boston Scientific has positive spinal cord stimulation data

The WaveWriter Alpha spinal cord stimulator systems [Image courtesy of Boston Scientific]Boston Scientific (NYSE: BSX) + announced positive one-year results from a trial evaluating its spinal cord stimulation (SCS) technology.

The SOLIS randomized control trial demonstrated sustained pain relief with the WaveWriter Alpha SCS system for treating non-surgical back pain (NSBP). Boston Scientific presented data at the 2024 North American Neuromodulation Society (NANS) meeting in Las Vegas.

Dr. James North presented findings from SOLIS, which evaluated 128 randomized subjects. At the primary endpoint interval, 90% of patients treated with WaveWriter reported significant pain relief of 50% or greater without an increase in opioids. Just 8% of patients treated with conventional medical management alone reported the same level of relief.

At one year, 84% of patients treated with WaveWriter reported 50% or greater pain reli…

Boston Scientific to acquire Axonics for $3.7B

Boston Scientific (NYSE: BSX) + announced today that it agreed to acquire Axonics (Nasdaq:AXNX) in a deal worth approximately $3.7 billion.

Shares of AXNX skyrocketed before the market opened today, rising 21.1% to $69.72 apiece. Shares of BSX stayed even.

Marlborough, Massachusetts-based Boston Scientific priced the acquisition at $71 in cash per share. It amounts to an equity value of about $3.7 billion and an enterprise value of approximately $3.4 billion.

Irvine, California-based 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. Axonics also launched the recharge-free F15 SNM system in mid-2022.

Axonics’ technology delivers mild electrical pulses to the sacral nerve, restoring communication between the brain and the bladder. The company also offer…

Boston Scientific initiates new Farapulse trial, expects FDA approval in 2024

The Farapulse PFA system. [Image courtesy of Boston Scientific]Boston Scientific (NYSE: BSX) + announced today that it initiated the AVANT GUARD clinical trial to evaluate its Farapulse pulsed-field ablation (PFA) system.

The company also says it now anticipates FDA approval for Farapulse in the first quarter of 2024.

AVANT GUARD looks at the safety and effectiveness of Farapulse as a first-line treatment for persistent AFib. Boston Scientific says this makes it the only trial studying the use of PFA as a frontline therapy in patients with this form of AFib.

Farapulse is already a known commodity in the competitive PFA space. The nonthermal treatment uses electric fields to selectively ablate heart tissue.

Boston Scientific bought Farapulse for nearly $300 million in 2021. The company shared its high hopes for the technology at its Investor Day event earlier this year, with analysts projecting FDA approval a…

The top medtech trends of 2023

The top medtech trends of 2023 included innovations such as artificial intelligence, new GLP-1 weight loss drugs and some long-awaited medtech finally receiving regulatory nods.

With health providers facing additional challenges on top of an ever-uncertain economic environment, medtech companies also made major readjustments: layoffs, spinoffs, reorganizations and much more.

Here are the top stories that caught the attention of MassDevice readers and editors in 2023.

Top 2023 medtech trend No. 10: Questions about GLP-1 drugs

U.S. health providers wrote more than 9 million prescriptions in just three months for Wegovy, Ozempic and similar glucagon-like peptide-1 (GLP-1) weight loss drugs, according to analytics firm Trilliant Health. The popularity and initial effectiveness of the new drugs had medtech industry analysts asking a lot of questions about how the potential health benefits could reduce demand for devices. Medical device executives, however, we…

Medtronic PulseSelect pulsed field ablation wins FDA approval

The Medtronic PulseSelect Pulsed Field Ablation (PFA) System is designed to treat paroxysmal and persistent atrial fibrillation (AFIb). [Image courtesy of Medtronic]The FDA has approved the Medtronic (NYSE: MDT) + PulseSelect Pulsed Field Ablation (PFA) System, the device developer said today.

PulseSelect is the first PFA technology approved for use in the U.S., as well as the first PFA technology with FDA breakthrough designation to win approval.

The minimally invasive, cardiac ablation system is indicated for the treatment of paroxysmal and persistent atrial fibrillation (AFIb).

Medtronic said it will start commercialization in early 2024.

“Launching the first FDA-approved PFA technology is not just a milestone; the PulseSelect PFA system is setting a new standard in safety for AF ablation with excellent efficacy and efficiency,” Medtronic SVP and Cardiac Ablation Solutions President Rebecca Se…

‘A safe pair of hands’ — Medtech’s investment in Ireland continues to grow

Killilagh, Ireland. [Image by Sean Whooley]Medtech established its presence in Ireland many years ago and still, companies continue to invest in the ever-growing country.

Boston Scientific established operations in Ireland in 1994, while Abbott has more than 70 years in the country. Medtronic, now officially headquartered in Dublin, has spent more than 40 years in Ireland and even hosted its 2023 annual meeting in the country.

Those companies, plus many more, continue to invest in Ireland, while more big names in medtech are coming to the table. Dexcom, for instance, earlier this year chose Athenry as its first European manufacturing location with a more than $325 million investment.

Speaking to MassDevice, Dexcom EVP of Global Operations, Barry Regan, explained what attracted the company to the growing medtech hub.

“One way I would describe Ireland when it comes to medtech operations and manufacturing is it’s a safe pair of hands,”…

Boston Scientific closes Relievant Medsystems acquisition

The Intracept procedure. [Image from Relievant Medsystems]Boston Scientific (NYSE: BSX) + announced today that it completed its previously announced acquisition of Relievant Medsystems.

In September, Boston Scientific announced plans to acquire Relievant for an upfront cash payment of $850 million. Additional payments are contingent on sales performance over the next three years. Minneapolis-based Relievant developed and commercialized the Intracept intraosseous nerve ablation system for chronic pain. The minimally invasive, FDA-cleared, same-day, outpatient procedure treats chronic vertebrogenic low back pain.

The procedure utilizes targeted radiofrequency energy to ablate the basivertebral nerve (BVN). This stops the nerve from transmitting pain signals to the brain. The procedure takes approximately one hour to perform. Boston Scientific says the Intracept system adds to its chronic pain portfolio.

Relievant rec…

Boston Scientific wins FDA approval for penile prosthesis pump

The AMS 700. [Image from Boston Scientific]Boston Scientific (NYSE: BSX) + announced that the FDA granted approval for its Tenacio pump component for its AMS 700 inflatable penile prosthesis (IPP).

The AMS 700 IPP offers a treatment option for patients with erectile dysfunction. It features three parts. The system has a pair of cylinders implanted in the penis, a pump placed in the scrotum and a saline reservoir in the lower abdomen. By squeezing the pump, the IPP inflates to hold an erection for as long as a person wants.

Boston Scientific acquired the AMS 700 IPP in its $1.6 billion buy of Endo Health Solutions in 2015. The new Tenacio pump adds automation to the system. It immediately initiates automatic deflation of the prosthesis with a single full depress of the deflation button.

According to Boston Scientific, the company engineered the pump to address unmet user needs related to pu…

Boston Scientific has more positive Farapulse pulsed-field ablation data

Part of the Farapulse pulsed-field ablation system, the Farawave single-shot catheter is designed to create durable and circumferential lesions. [Image courtesy of Boston Scientific]Researchers shared positive data from a large, real-world registry of patients treated with the Boston Scientific (NYSE: BSX) + Farapulse system.

Data from more than 17,000 patients in the MANIFEST 17K registry reinforced the real-world safety profile for the pulsed-field ablation (PFA) system. Results included no reports of permanent phrenic nerve palsy, pulmonary vein stenosis or esophageal injury. The company reported an overall major adverse event rate of less than 1%.

The registry included outcomes ranging across 106 hospitals, according to Boston Scientific. Data also reinforced the reproducibility of the therapy workflow and short learning curve in uncontrolled commercial use.

Boston Scientific presented its Farapulse data at the…

Boston Scientific shares positive drug-coated balloon data

The Agent drug-coated balloon. [Image from Boston Scientific]Boston Scientific (NYSE: BSX) + announced positive data from a trial of its Agent drug-coated balloon (DCB).

The Marlborough, Massachusetts-based company presented its results at the Transcatheter Cardiovascular Therapeutics (TCT) meeting. Data demonstrated statistical superiority for Agent compared to uncoated balloon angioplasty.

AGENT IDE evaluated the safety and effectiveness of using a DCB to treat coronary in-stent restenosis (ISR). The paclitaxel-coated balloon catheter offers an alternative to treatments like stent layering or radiation. It’s designed to re-open vessels and transfer the therapeutic drug to the vessel wall, helping to prevent ISR reoccurrence.

The Agent DCB has FDA breakthrough device designation.

Boston Scientific set a primary endpoint of target lesion failure at 12 months. Agent DCB topped balloon angioplasty with 1…

The biggest cardiovascular stories from TCT 2023

Every year, some of the biggest names in cardiovascular technologies come together in one place for TCT.

This year’s 35th edition of the Transcatheter Cardiovascular Therapeutics annual scientific symposium was no different in San Francisco.

Usual suspects like Medtronic and Abbott released data covering a range of products, while other big names like Edwards, GE HealthCare and more had positive updates on their own technologies.

Last year’s TCT event highlighted some significant trends in the cardiovascular space. Let’s see what this year’s symposium brought.

Abbott’s TriClip, MitraClip shine along with drug-eluting stent

Results from Abbott’s TRILUMINATE pivotal trial reinforced the safety and effectiveness of the TriClip system. Abbott also shared data from the MitraClip EXPAND G4 real-world registry at TCT 2023.

TriClip, a transcatheter edge-to-edge repair (TEER) system, treats patients with symptomat…

Boston Scientific stock rises on Street-beating Q3, raised EPS guidance

Boston Scientific (NYSE: BSX) + shares ticked up today on third-quarter results that came in ahead of the consensus forecast.

Shares of BSX were up slightly at $50.44 apiece by midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies —was down more than 1%.

Truist analysts described the results as another solid quarterly organic revenue beat.

The Marlborough, Massachusetts–based medtech company posted profits of $505 million. That equals 34¢ per share, on sales of more than $3.5 billion for the three months ended Sept. 30, 2023.

Boston Scientific posted a massive bottom-line gain — nearly three-fold — on sales growth of 11.2%.

Adjusted to exclude one-time items, earnings per share came in at 50¢. That landed 2¢ ahead of expectations on Wall Street. Sales also topped estimates of $3.47 billion.

The company reporte…