Boston Scientific Archives - Page 18 of 19

Boston Scientific’s next-gen stroke prevention device gets FDA nod

The FDA has approved the next-generation of Boston Scientific’s (NYSE:BSX) Watchman left atrial appendage closure (LAAC) device, the company announced today.

The Marlborough, Mass.-based company describes the Watchman FLX as a permanent implant designed to close off the left atrial appendage and thus reduce the risk of stroke without the bleeding danger associated with blood-thinners. It is indicated for people who have atrial fibrillation that is not caused by a heart valve problem.

Boston Scientific touted the Watchman FLX as easier to implant, re-capturable and re-positionable. The device has a new frame design that allows for optimal engagement with the tissue for long-term stability and a faster, more complete seal, the company added. It received the CE Mark in Europe in March 2019.

Watchman FLX’s fully rounded design offers physicians the ability to safely enter, and maneuver within, the left atrial appendage, the company said. It is availabl…

Boston Sci reportedly looking to sell snake antivenom business

[Photo by Conscious Design on Unsplash]

Boston Scientific (NYSE:BSX) is exploring selling its snake antivenom products business, according to Bloomberg, which cited anonymous sources.

A Boston Sci spokesperson told MassDevice via email that the company has a practice of not commenting on speculation.

Boston Scientific acquired the antivenom business during its $4 billion acquisition of BTG, which closed last year. Its products include CroFab, touted as the only FDA-approved product exclusively derived from U.S. snakes. CroFab to date has treated more than 50,000 people suffering from bits from snakes including rattlesnakes, copperheads and cottonmouths/water moccasins.

The BTG acquisition also included devices for vascular and oncology applications, as well as drugs for treating overdoses.

Boston Scientific wins FDA clearance for insertable cardiac monitor

Boston Scientific (NYSE:BSX) today said it received FDA 510(k) clearance for its Lux-Dx Insertable Cardiac Monitor System.

The system is a long-term diagnostic device that is implanted into patients to detect arrhythmias associated with atrial fibrillation, cryptogenic stroke and syncope.

Lux-Dx is designed with a dual-stage algorithm that can detect and verify potential arrhythmias before sending an alert to clinicians. The device uses the Latitude Clarity Data Management System to enable remote programming and allow physicians and care teams to adjust event detection settings without requiring in-person appointments.

“For physicians, receiving accurate monitoring data and having remote access to programming provides the opportunity to operate with more efficiency and confidence,” senior VP and chief medical officer of rhythm management and global health policy Kenneth Stein said in a news release. “The LUX-Dx ICM System is designed to…

Boston Scientific touts SpaceOAR meta-analysis results

Boston Scientific (NYSE:BSX) announced that published results from an analysis of its SpaceOAR hydrogel spacer revealed safe prostate-rectum separation.

Marlborough, Mass.-based Boston Scientific has developed the SpaceOAR since its $600 million acquisition of Augmenix in September 2018. The absorbable polyethylene glycol hydrogel spacer won CE Mark approval in the European Union in 2010 and 510(k) clearance from the FDA in April 2015 and is designed for separating the prostate from the rectal wall during radiation treatment for prostate cancer.

Results from the study, published in the Journal of the American Medical Association, found that the safe prostate-rectum separation was sufficient enough to reduce v70 rectal irradiation and was associated with lower rectal toxicity and higher bowel quality of life in late follow-up.

The meta-analysis included randomized controlled trials and real-world results of 1,011 prostate cancer …

Medtech manufacturers must add warning label to drug-eluting PAD devices

UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks.

A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for late death compared to people treated with uncoated balloons. Led by Dr. Konstantinos Katsanos, researchers looked at data from 28 trials and discovered that there was a 68% relative risk increase in all-cause death with paclitaxel-coated devices after 5 years and a 93% relative risk after 5 years compared to therapy with an uncoated balloon.

Labeling changes will apply to instructions for use of these devices throughout Europe and will include a warning and a summary of the Katsanos publication plus supplemented with the clinical data specific to each device. No device…

CMS moves to boost access to Boston Sci’s single-use duodenoscope

The Exalt Model D single-use duodenoscope from Boston Scientific [Image courtesy of Boston Sci]

Boston Scientific (NYSE:BSX) announced today that CMS will speed up Medicare beneficiaries’ access to single-use endoscopes, including Boston Sci’s Exalt Model D single-use duodenoscope.

The Centers for Medicare & Medicaid Services (CMS) granted a Boston Sci application for a plication for a transitional pass-through (TPT) payment category — an only months-old payment category meant to provide people with access to innovative medical technologies while needed cost data is collected.

Single-use duodenoscopes matter. The devices provide a less invasive way than traditional surgery to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other gastrointestinal conditions. But reprocessing the scopes has proved especially tricky — with the scopes in the past conne…

U of M releases Coventor ventilator design as open-source

The University of Minnesota recently announced that it released the design for its Coventor alternative ventilator as open-source.

Minnesota’s Coventor low-cost device gained notoriety in March after researchers touted the design made from various parts totaling just $150. In April, it became the first ventilator of its kind authorized for use under the FDA’s EUA for the COVID-19 pandemic.

Also in April, Boston Scientific (NYSE:BSX) announced that it was sole manufacturer of the device, which the company said it expects to sell at-cost at approximately $1,000 per unit.

The Coventor is now available to companies who are interested in manufacturing it. They can sign a free electronic license and download the manufacturing specifications.

“From the outset, the mission of this project was to make this emergency device available to people in need, wherever they might be in the world, as quickly and safely as possible,” Dr. Stephen Richardson, a…

The George Floyd case has rocked a major U.S. medtech hub: Here’s what industry leaders think

Memorial to George Floyd in Minneapolis (Image from Boston Scientific)

Major medtech companies with a presence in the Minnesota have been chiming in with commentary on the death of George Floyd in police custody and the resulting demonstrations and violence.

Thousands of people have taken to the streets across the country since the Memorial Day death of Floyd, 46, in Minneapolis. The unarmed black man died while a Minneapolis police officer pressed his knee on Floyd’s neck and bystanders pleaded for the officer to stop.

As a video of his death began to circulate, some protestors began staging peaceful demonstrations in the Twin Cities. Others turned to violence, smashing storefront windows, looting, and burning down a police station and several businesses in Minneapolis and St. Paul. Demonstrations have spread across the country in the ensuing week.

In an open letter to employees on Friday, Bos…

Medtech 100 roundup: Stocks peak to end May

Medtech stocks hit their highest point since before the COVID-19 pandemic rocked the markets as May came to a close last week.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 87.17 points at the end of last week (May 29). That total represents a 2.3% gain from the 85.22-point total at the same time a week prior (May 22).

The lowest point during the pandemic remains at 62.13 on March 23. Since then, medtech stocks have experienced 40.3% growth in total, marking the highest rise the index has seen since its previous mid-pandemic high of 85.77 on May 4.

However, the stocks are down 5.6% since the index’s pre-pandemic crash high point of 92.32 on Feb. 19, although that is the smallest margin of decline over the past three months.

Compared to the S&P 500 Index, which experienced a 3% increase from May 22 to May 29, the medtech index took a similarly sizeable leap. The Dow Jones Index f…

Boston Sci launches DirectSense technology

Boston Scientific (NYSE:BSX) announced today that it launched its DirectSense for monitoring the effect of radiofrequency (RF) energy during cardiac ablation procedures.

Marlborough, Mass.-based Boston Scientific’s DirectSense is available on the Rhythmia HDx mapping system that won FDA approval in April. Rhythmia HDx monitors changes in local impedance — electrical resistance — around the tip of the IntellaNav MiFi open-irrigated ablation catheter.

DirectSense offers data on the impedance around the catheter tip, measuring the ability of the tissue to respond to RF energy before physicians deliver therapy, according to a news release. It tracks local impedance change during ablation to help understand how the tissue is affected, leading to a reduction in the chances of over-ablation and complications.

Data from the Localize retrospective clinical trial showed a local impedance decrease of ≥16.6 ohms with an inter-lesion spacing of ≤ 6mm sh…

Boston Scientific execs address George Floyd’s death in Minneapolis

Memorial to George Floyd in Minneapolis (Image from Boston Scientific)

Boston Scientific (NYSE:BSX) executives today urged U.S. employees to talk, listen and take action against racism and violence, citing Monday’s death of a black man while in police custody in Minneapolis.

George Floyd, 46, died while a Minneapolis police officer pressed his knee on Floyd’s neck and bystanders pleaded for the officer to stop. One witness’s video showed the handcuffed Floyd saying, “I can’t breathe,” and asking for his mother. The officer was arrested today and charged with third-degree murder and manslaughter, according to the Hennepin County (Minn.) Attorney.

In an open letter to employees, Boston Scientific noted that it has about 9,000 workers in the Minneapolis area, which this week has been the scene of protests and riots in which several buildings, including a police precinc…

Boston Scientific raises $2b in concurrent stock offerings

Boston Scientific (NYSE:BSX) announced that it completed concurrent offerings of common stock and preferred stock totaling nearly $2 billion.

One offering included nearly 29.4 million shares of common stock with an option to purchase up to 3.8 million more shares priced at $34.25 per share. The other consisted of almost 10.1 million shares of 5.5% mandatory convertible preferred stock, including an overallotment option to purchase up to 1.3 additional shares at $100 per share.

According to a news release, proceeds from the common stock offering total $974.7 million and the preferred stock offering is set to bring in $974.6 million, including the exercise of the underwriters’ options in full. The company commenced the concurrent offerings just last week.

Boston Scientific intends to use a portion of the proceeds to repay in full the remaining $750 million outstanding under its $1.25 billion term loan credit facility maturing on April 20, 2021. The r…