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Boston Scientific wins FDA approval for radioembolization tech

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Boston Scientific (NYSE:BSX) announced today that it received FDA approval for its TheraSphere Y-90 glass microspheres.

Marlborough, Mass.-based Boston Scientific’s TheraSphere Y-90 glass microspheres were developed to treat those with hepatocellular carcinoma (HCC), according to a news release.

Approval for the technology offers further access to the therapy that, until now, has been utilized under a humanitarian device exemption. Boston Scientific said it is now the only radioembolization technology indicated for the treatment of unresectable HCC in the U.S.

TheraSphere provides a type of selective internal radiation therapy (SIRT) with low toxicity, comprised of millions of microscopic glass beads containing radioactive yttrium (Y-90). The glass beads are delivered directly to liver tumors via a catheter to ensure there is minimal exposure to surrounding healthy tissue.

The Legacy study of 162 participants tha…

MedTech 100 roundup: Industry rebounds from massive dip

The medtech industry saw its largest fall in several months last week, but it has rebounded slightly after a couple of bad weeks.

A strong start to 2021 hit a skid at the end of February and carried over into March, with MassDevice‘s MedTech 100 index hitting its lowest point on March 8 (102.16). It had only notched an all-time best of 110.96 on Feb. 15, leading to a precipitous fall not seen since October.

While the heights of last month have not yet been returned to, the industry has shown signs of bouncing back. The index ended the week (March 12) at 104.62, marking a 1.3% rise from the 103.3-point mark set one week before (March 5).

The industry remains in a strong position and one that is particularly stronger than it was at this time a year ago, as the index is now 13.3% up on the pre-COVID-19 pandemic high of 92.32 set on Feb. 19, 2020.

Nearly one year ago, on March 23, 2020, as the pandemic took hold, the industry sat at 62.13 points on th…

DTW Podcast: CEO Petrovic explains how Insulet is switching people to `Pods

Insulet CEO Shacey Petrovic says she didn’t jump immediately at the chance to join the company.

In an interview with the DeviceTalks Weekly Podcast, Petrovic, who was serving as CEO of a women’s health company when CEO-Patrick Sullivan, her former boss at Cytyc, called her with an offer to serve as Insulet’s chief commercial officer

“I said, `Well, Pat, I’m a CEO now, you know, didn’t you hear?,” she joked.

A chief commercial officer role might be seen as a backward step from CEO, but Sullivan framed the question differently. He told Petrovic that he came out of retirement to take the CEO role and didn’t want to a long stint as CEO. “He said, `This could be your opportunity to eventually run a public company. If it goes well, I need a successor, the technology is remarkable, and together we can fix this problem.’”

A path the CEO role at a publicly traded company was certainly appealing. But Petrovic had more personal reason for the jo…

MedTech 100 roundup: Industry sees largest fall since October

The medtech industry’s hot start to 2021 has finally come to a full halt after stocks fell harder than they had in more than four months.

MassDevice‘s MedTech 100 index ended the week (March 5) at 103.3 points, marking a -3.1% dip from the 106.65-point mark set one week before (Feb. 26). In less than a month, the fall has been more than seven points from the end-of-week tally of 110.63 points on Feb. 12.

Medtech’s lowest point of the week was on Thursday, March 4, when it fell to 102.85. The overall drop of about five points from the 107.88-point mark set on Monday, March 1, is the largest dip since the index slid from 97.2 to 91.01 between Oct. 23, 2020, and Oct. 30, 2020.

The all-time best for the index was 110.96, set just three days after that. The index had never reached even the 100-point mark before November 2020.

Still, the industry is in much better condition than it was around this time last year. Medtech’s latest mark means …

DTW Podcast: Can AI, advanced imaging and robotics “democratize” surgery?

A new generation of digital surgery systems will level the playing field for surgeons giving them artificial intelligence, robotic tools and other assistive technologies.

In three interviews in this week’s DeviceTalks Weekly Podcast, leaders form Asensus, ActivSurgical and Memic explain how their systems will improve surgeon performance, reduce errors, and deliver the “democratization” of surgical robotics.

Guests this week include

Anthony Fernando, CEO of Asensus Surgical (formerly Transenterix), outlines the company’s bid to push its Sehance system as a solution for laparoscopic procedures. Fernando, who took over as CEO in 2019, explains why the company’s stock crashed in 2019 and details the changes that he says has started the company’s turnaround. Senhance offers more responsive surgical tools along with data that will help with surgical training and scheduling.

Todd Usen, CEO of ActivSurgical, left a job he loved at Olympus to lead a compan…

ControlRad gains clearance for imaging tech to sell to Boston Sci

ControlRad announced today that it received FDA 510(k) clearance to market its ControlRad Select radiation reduction technology.

Atlanta-based ControlRad’s technology uses proprietary semi-transparent filters with a user-interface tablet and imaging processing algorithms that are retrofitted onto customers’ existing Siemens Artis zee interventional imaging systems, according to a news release.

ControlRad, ahead of its commercialization efforts for the platform, also entered into an exclusive agreement with Boston Scientific (NYSE:BSX) to sell the ControlRad Select technology.

“With the FDA clearance and the reach of the global medical device sales team, every cath, EP, and IR lab in the country that has a Siemens Artis zee will now have the opportunity to reduce their radiation dose by 85% without compromising image quality,” ControlRad CEO Guillaume Bailliard said in the release.

Boston Scientific to acquire Lumenis surgical business for $1.07B

Boston Scientific (NYSE:BSX) announced today that it entered into a definitive agreement to acquire the global surgical business of Lumenis for nearly $1.1 billion.

Marlborough, Mass.-based Boston Scientific entered into the agreement with an affiliate of Baring Private Equity Asia (BPEA) to acquire the global surgical business of the privately-held company developing and commercializing energy-based medical solutions. The deal includes an upfront cash payment of $1.07 billion, subject to closing adjustments, according to a news release.

BPEA is slated to retain ownership of the Lumenis global aesthetics and ophthalmology businesses, while Boston Scientific picks up a surgical business expected to bring in 2021 revenues of approximately $200 million. The company expects the deal to be completed in the second half of 2021, with an immaterial impact on adjusted earnings per share this year. EPS impact is expected to be 2¢ accretive in 2022 and increasingly accret…

Boston Scientific completes Preventice buy, divests BTG Pharmaceutical business

Boston Scientific (NYSE:BSX) announced that it completed its acquisition of Preventice Solutions that could be worth up to $1.225 billion.

The transaction includes a cash payment of $925 million upfront with up to an additional $300 million in potential commercial milestone payments available. Accounting for the company’s approximately 22% equity stake in Preventice prior to the acquisition, the deal will be worth approximately $720 million upfront and $230 million in potential milestone payments, according to a news release.

Marlborough, Mass.-based Boston Scientific announced the planned acquisition of Minneapolis-based Preventice on Jan. 21, 2020.

Preventice designs mobile health solutions and remote monitoring offerings for patients with cardiac arrhythmias. Among its products are wearables, including the PatientCare platform and BodyGuardian family of monitors.

BodyGuardian monitors use a fully-integrated, cloud-based platform for clini…

Nevro posts Street-beating Q4 results

Nevro (NYSE:NVRO) posted fourth-quarter results that beat the consensus forecast on Wall Street as it issued 2021 guidance that was slightly below analysts’ expectations.

The Redwood City, Calif.–based spinal cord stimulation system maker reported a loss of –$7.2 million, or –21¢ per share, on sales of $109.7 million for the three months ended Dec. 31, 2020, versus a loss of –$13.5 million, or –44¢ per share, on sales of $114.3 million in Q4 2019.

The results beat the expectations of The Street, where analysts on average predicted a loss of –33¢ per share on sales of $107.4 million.

“Both U.S. and international revenue was meaningfully impacted by the resurgence of COVID activity in the second half of the quarter,” CEO D. Keith Grossman said during an earnings call yesterday evening.

Grossman later added: “I really believe we’re well-positioned for attractive and sustainable growth as the pressure of COVID on our busi…

Boston Scientific has another serious recall on the same heart device

The FDA has declared a second Class I recall within a month on a Boston Scientific implantable cardioverter defibrillator (ICD).

This recall, which the company initiated with a trio of warnings in December, notified physicians that 3,350 Emblem S-ICD model A209 and A219 devices may exhibit electrical overstress while delivering high-voltage therapy. Variations in header assembly may allow a “very small pathway” to develop, allowing moisture to penetrate the device and cause it to short out during high-voltage therapy, the warning said.

Get the full story on our sister site, Medical Design & Outsourcing.

The worst catheter-based device recalls of 2020

Top: Teleflex Langston Dual Lumen catheter; Bottom: BSX Imager II, Endologix Ovation iX, Teleflex AC3 Optimus Intra-Aortic balloon pump

The U.S. saw nine serious medical device recalls related to catheters in 2020 — up from four the previous year, according to the FDA.

FDA in 2020 reported a total 33 medical device recalls at its most serious Class I level, down from 49 in 2019.

The list of the most serious catheter-based device recalls in 2020 includes products from major companies including Medtronic and Teleflex, and catheters ranging from congenital heart treatment devices to contrast material delivery devices.

Here are the nine most serious catheter-based device recalls of 2020.

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Federal lawsuit over Boston Sci pelvic mesh heads to trial

A federal judge in Arkansas has ruled that most counts in a pelvic mesh lawsuit against Boston Scientific can go to trial.

Kortney Cline sued Boston Sci in 2014, claiming that she suffered injuries after implantation with the company’s Obtryx trans-obturator mid-urethral sling in 2009.

Cline’s case was recently transferred to federal court in Arkansas from West Virginia, where it had been one of seven multi-district litigations. U.S. Judge Timothy L. Brooks in Arkansas, in an order dated Feb. 11, found that seven of the 10 counts in Cline’s lawsuit can proceed to trial.

Brooks among other things found “genuine, material disputes of fact” over whether Boston Sci should have used Marlex polypropylene in the Obtryx device. The judge also found that Cline had raised a “triable question of fact” over whether Boston Sci failed to entirely warn the doctor who implanted the Obtryx device in Cline.

Brooks also said…