Nuvasive Archives - Page 3 of 4 - Medical Design Sourcing

NuVasive launches newest porous PEEK implant for posterior spine surgery

NuVasive (NSDQ:NUVA) announced today that it launched the Cohere TLIF-O porous PEEK implant for posterior spine surgery.

San Diego-based NuVasive also confirmed a planned launch for its Cohere TLIF-A implant for later in the fourth quarter of this year. According to a news release, NuVasive is the only company to offer both porous PEEK and porous titanium implants for posterior spine surgery with the new additions to its advanced materials science portfolio.

Cohere TLIF-O, a porous PEEK implant for transforaminal lumbar interbody fusion (TLIF), features a proprietary porous surface technology to generate stronger integration through bony in-growth and on-growth, while its design with lordosis in the oblique plane helps to maintain coronal alignment while restoring sagittal balance.

The platform also features a radiolucent polymer composition to enable clear radiographic visualization of the fusion site with a variety of different imaging modalities.

…

Medtronic, Johnson & Johnson warn of hospital worker burnout headwind for medical devices

[Photo by Eugene Chystiakov]Medical device manufacturers are worried that the COVID-19 pandemic’s latest wave will make for a tougher recovery in elective procedures after Delta variant cases subside.

Top officials from Medtronic (NYSE:MDT), Johnson & Johnson (NYSE:JNJ), NuVasive (NASDAQ: NUVA) and Zimmer Biomet Holdings (NYSE:ZBH) warned investors that the highly contagious COVID-19 mutation filling U.S. hospitals with mostly unvaccinated patients is leaving a lasting mark on the healthcare workers who will be needed to catch up on routine procedures.

Johnson & Johnson’s hardest-hit business in the pandemic is its Medical Devices line, which faces another slowdown from elective procedures again delayed due to the Delta wave. But a looming shortage of hospital system workers is “a little bit of a new dynamic” facing the business, J&J CFO Joseph Wolk said Wednesday at the Morgan Stanley Global Healthcare Conference.

Get the full story at our sist…

Medtronic, Johnson & Johnson warn of hospital worker burnout headwind for medical devices

[Photo by Eugene Chystiakov]

Medical device manufacturers are worried that the COVID-19 pandemic’s latest wave will make for a tougher recovery in elective procedures after Delta variant cases subside.

Top officials from Medtronic (NYSE:MDT), Johnson & Johnson (NYSE:JNJ), NuVasive (NASDAQ: NUVA) and Zimmer Biomet Holdings (NYSE:ZBH) warned investors that the highly contagious COVID-19 mutation filling U.S. hospitals with mostly unvaccinated patients is leaving a lasting mark on the healthcare workers who will be needed to catch up on routine procedures.

Johnson & Johnson’s hardest-hit business in the pandemic is its Medical Devices line, which faces another slowdown from elective procedures delayed again due to the Delta wave. But a looming shortage of hospital system workers is “a little bit of a new dynamic” facing the business, J&J CFO Joseph Wolk said Wednesday at the Morgan Stanley Globa…

NuVasive creates new C-level positions

NuVasive (NSDQ:NUVA) announced that it added chief commercial officer and chief technology officer as new executive leadership roles.

Effective immediately, Massimo Calafiore will assume the position of chief commercial officer, while Ryan Donahoe was appointed as chief technology officer, with both reporting directly to CEO J. Christopher Barry. In connection with the new leadership structure, EVP of the company’s global commercial business Brent Boucher will transition from the company.

As CCO of the San Diego-based spine surgery tech company, Calafiore will oversee product marketing, commercial and commercial enablement functions, as well as the company’s specialized orthopedics and clinical services, according to a news release.

Calafiore joined NuVasive in 2017, most recently serving as EVP of global business units. He previously spent 16 years supporting and leading the U.S. business for Waldemar Link.

Donahoe, a 15-year veteran …

Nuvasive sales up 45% in Q2

NuVasive (NSDQ:NUVA) this week posted second-quarter results that beat the overall consensus on Wall Street.

The San Diego-based company reported profits of $1.8 million, or 3¢ per share, on sales of $294.8 million for the three months ended June 30, for a sales growth of 44.8% compared with Q2 2020.

Adjusted to exclude one-time items, earnings per share were 60¢, 16¢ ahead of The Street, where analysts were looking for sales of $285.1 million.

“Nuvasive continued to see the spine market stabilize throughout the second quarter, providing us the opportunity to help more surgeons and patients around the globe. Our continued investments in the cervical and anterior procedural segments and our international commercial organization are advancing both our near- and long-term growth strategy,” CEO Christopher Barry said in a news release.

“Following our latest CE certification, the Pulse platform clinical evaluations and surgeon feedback have exceeded ou…

Nuvasive launches ALIF 3D printed porous titanium implant

Nuvasive this week announced that it has launched its Modulus ALIF 3D printed porous titanium implant for anterior lumbar interbody fusion.

San Diego-based Nuvasive designed Modulus for enhanced osseointegration, according to the company. It has a porous surface architecture engineered for fusion and promotes new bone on-growth and in-growth. The design also allows for enhanced visualization compared to solid titanium implants.

“Modulus ALIF has been one of NuVasive’s most successful clinical evaluations to date with continued surgeon adoption and overwhelmingly positive feedback. This differentiated technology furthers our position to become the market leader in ALIF and extends our Modulus portfolio across all procedural segments,” Massimo Calafiore, executive VP of global business units at Nuvasive, said in a news release. “We are leveraging our experience as the leader in lateral surgery to deliver outcome-driven innovation to fuel c…

Report: Medtech dollars, deals hit new highs in first half of 2021

Fueled at least in part by exceptionally strong IPO and M&A markets, hedge funds, venture capitalists, private equity firms and corporate investors are committing more time and money into privately held medical devices companies, according to a new “Healthcare Investments and Exits” report issued by Silicon Valley Bank.

The report examining the first half of 2021 outlines deals and dollars committed to all sectors within healthcare — while also tracking exiting opportunities for investors. An examination of the medical device portion of the report reveals many promising trends.

First, capital commitments are up. Looking at dollars raised, U.S. and European medical device startups raised $4.6 billion in the first half of this year, putting 2021 on pace to eclipse totals dollars raised in 2020 ($5.2 billion raised) and 2019 ($4.8 billion raised.) It’s worth noting that European startups accounted for 34% of the dollars raised by medical device companies, up f…

FDA raises concerns about NuVasive Magec devices

The FDA today issued a notice warning patients, caregivers and healthcare providers of potential issues with Magec devices from NuVasive (NSDQ:NUVA).

NuVasive’s Magec, a growing spinal rod system intended for use in children under 10, uses magnets to help correct spinal deformities as the child grows. The company designed Magec to help avoid multiple operations while correcting the spinal curve.

According to the FDA release, there are reports describing endcap separation, O-ring seal failure and potential exposure of internal components of the Magec devices to living tissue that may lead to adverse local tissue reactions. The issues stretch to the following Magec devices:

MAGEC Spinal Bracing and Distraction System MAGEC 2 Spinal Bracing and Distraction System MAGEC System MAGEC System Model X device MAGEC System Model X rod MAGEC System Rods

The FDA said that, in 2020, NuVasive made changes to the Magec device design to address issues with endca…

FDA warns of biocompatibility concerns with NuVasive’s Precise devices

The FDA today informed healthcare providers of potential biocompatibility concerns with Precice devices from NuVasive (NSDQ:NUVA).

Precice devices are implants for those 18 years of age and older and are used to lengthen the limb, shorten or compress the limb or transport segments of long bones. They include adjustable rods that are placed inside a patient and are driven by an internal magnetic mechanism.

According to an FDA notice, there have been reports describing pain and changes in surrounding bone and soft tissue in patients with the stainless steel-based Precice devices. The adverse events could be related to corrosion, wear and previously unanticipated exposure of components that are undergoing biocompatibility testing.

Get the full story on our sister site MassDevice.

FDA warns of biocompatibility concerns with NuVasive’s Precise devices

The FDA today informed healthcare providers of potential biocompatibility concerns with Precice devices from NuVasive (NSDQ:NUVA).

Precice devices are implants for those 18 years of age and older and are used to lengthen the limb, shorten or compress the limb or transport segments of long bones. They include adjustable rods that are placed inside a patient and are driven by an internal magnetic mechanism.

According to an FDA notice, there have been reports describing pain and changes in surrounding bone and soft tissue in patients with the stainless steel-based Precice devices. The adverse events could be related to corrosion, wear and previously unanticipated exposure of components that are undergoing biocompatibility testing.

NuVasive posted a statement on April 5 to inform healthcare providers of ongoing testing with Precice devices, placing a global ship hold for all of them.

The FDA noted that, at this time, it remains uncertain if the root c…

Nuvasive’s Pulse robot-assisted spinal surgery platform wins CE mark

NuVasive (NSDQ:NUVA) announced today that it received CE mark approval for its Pulse spinal surgical automation platform.

San Diego-based NuVasive touts its Pulse system as a first-of-its-kind technology designed to integrate radiation reduction, imaging enhancement, rod bending, navigation, intraoperative neuromonitoring and spinal alignment tools into one platform.

According to a news release, Pulse is currently the only enabling technology platform capable of utilization in 100% of spine procedures and throughout the entire operating room workflow. The company said it increases safety, efficiency and procedural reproducibility while addressing several common clinical challenges in spine surgery.

With CE mark approval, NuVasive said clinical evaluations for Pulse are now underway across multiple countries throughout Europe. Pulse has held FDA approval in the U.S. since July 2018.

“The latest CE mark approval and clinical evaluations are ke…

The 10 largest orthopedic device companies in the world

[Image from Pixaby]Pent-up demand could make orthopedic devices a hot space in 2021.

The COVID-19 pandemic was especially brutal for the orthopedic device industry. Many of the largest companies in the space saw double-digit percentage declines in revenue in 2020. Health providers delayed or canceled elective procedures to focus on the pandemic, and patients stayed away in droves.

It’s a new year now, though, and vaccines are rolling out. People don’t want to live with a bad knee or hip or back forever. Growth will eventually return for the industry, and orthopedic device companies are positioning themselves to be ready.

Rather than hunkering down during the pandemic, many ortho device companies chose shop for new technologies and major M&A deals. They’re reorganizing and launching new products ranging from surgical robots to smart implants.

Read on and discover the latest about the world’s 10 largest orthopedic device companies.

Next>>