Baxter Archives - Page 2 of 11 - Medical Design Sourcing

Baxter launches PerClot absorbable hemostatic powder

PerClot requires no premixing, which means it can be applied to a bleeding source during surgery within second. [Image courtesy of Baxter]Baxter (NYSE: BAX) + announced today that it launched the PerClot absorbable hemostatic powder in the U.S.

PerClot, a passive, absorbable hemostatic powder, received FDA approval in May. Artivion developed the powder and transferred full ownership to Baxter as part of a sale agreement struck in July 2021.

Artivion designed PerClot to control mild bleeding in specific surgical procedures. It comes ready to use for patients with intact coagulation. The powder’s granules have a molecular structure that rapidly absorbs water to form a gelled adhesive matrix. This provides a mechanical barrier against further bleeding. It also results in the accumulation of platelets, red blood cells and coagulation proteins.

“PerClot is a strong complement to Baxter’s leading hemostat por…

Baxter launches next-gen ICU bed

The Progressa+ ICU bed. [Image from Baxter/Hillrom]Baxter (NYSE: BAX) + announced today that it launched its new intensive care unit bed in the U.S.

The Hillrom Progressa+ bed offers new technology and features that make it easier for nurses to care for patients while supporting recovery. Deerfield, Illinois-based Baxter acquired Hillrom and offerings like the Progressa+ ICU bed for $12.5 billion in December 2021.

“Our new and improved Progressa+ is a ‘true ICU bed,’ designed for the realities of critical care, where patient needs are high and clinical staff can be stretched thin,” said Julie Brewer, president, Baxter patient support systems, global surgical solutions and care communications businesses. “We asked ICU care teams how we could make their jobs easier, and then designed the next generation of our leading ICU bed with features that help address challenges, such as reducing the strain on nursing resources, lesse…

CAPA doesn’t have to be a four-letter word, Medtronic Quality/Regulatory Director Kathryn Merrill says

[Illustration by Vitalii Vodolazskyi via Adobe Stock]

Medtronic Quality/Regulatory Program Director Kathryn Merrill is a problem-solver’s problem solver.

Right now, the problem she wants to solve is the way device manufacturers approach corrective and preventative actions — CAPA, an abbreviation that can trigger an avalanche of documentation and headaches for medtech engineers.

For five years, Merrill’s been part of a Medical Device Innovation Consortium (MDIC) team developing a new approach to CAPA, stemming out of conversations across the medtech industry and beyond. The goal was to implement improvements in months instead of years and allow teams to be more proactive.

“I’ve been at Medtronic for 26 years and very often we’d say, ‘Hey, I think we’re making this more complicated than it needs to be,'” said Merrill, who is lead co-author of MDIC̵…

New ethylene oxide rules could trigger sterilization consolidation — and new options

Firefighters training on a simulated ethylene oxide leak [Photo via Adobe Stock]

The largest commercial sterilizers will likely absorb the costs of new ethylene oxide (EtO) regulations — and could consolidate smaller competitors, according to a new analysis from Moody’s Investors Services.

Tighter controls on EtO emissions would increase capital spending and operating costs for all commercial sterilizers who use the toxic gas, which is the most commonly used method for eliminating infection-causing microbes from medical devices.

“Large companies have enough liquidity to fund the significant increase in spending without incremental debt,” Moody’s said in a subscribers-only report this week. “But the higher costs and compliance requirements could make the business less attractive for some small companies.”

The largest commercial sterilizers can absorb the cost of new…

A veteran Medtronic executive takes a new role at Baxter

Julie Brewer, president of Patient Support Systems, Global Surgical Solutions and Care Communications at Baxter [Image from Brewer’s LinkedIn profile]Medtronic Cardiovascular Diagnostics and Services President Julie Brewer has left for a new position at Baxter.

Brewer announced on LinkedIn near the end of last week that she has joined Baxter (NYSE: BAX) + as President of the Patient Support Systems, Global Surgical Solutions and Care Communications team.

“Baxter is a great company with a wonderful purpose of saving and sustaining lives,” Brewer said. “I spent the last couple of days meeting many on the team and came away energized and excited about the road ahead.”

Brewer also had positive words about Medtronic (NYSE: MDT) + , where she started as an area VP and rose through the ranks.

“After almost 17 years with Medtronic, I am mov…

Artivion gains FDA approval for PerClot, starts transfer to Baxter

PerClot requires no premixing, which means it can be applied to a bleeding source during surgery within second. [Image courtesy of Baxter]Artivion today announced FDA premarket application (PMA) approval of its PerClot absorbable hemostatic system designed to control bleeding in specific surgical procedures.

The Atlanta-based company will transfer full ownership to Baxter (NYSE: BAX) + , following a sale agreement that occurred in July 2021.

Artivion anticipates receiving an $18.75 million milestone payment under the terms of the agreement. Of this, $4.5 million will go to Artivion’s former partner, Starch Medical.

As part of the terms of the agreement, Artivion will supply Baxter with PerClot for a minimum of 21 months. This term will last until all manufacturing operations are successfully transferred to Baxter or its selected designee.

It’s an important milestone for Artivion

In a news release,…

Baxter CFO leaves for same role at GE HealthCare

Jay Saccaro. [Image from Baxter]Baxter (NYSE:BAX) announced today that its chief financial officer Jay Saccaro will depart for the same role at GE HealthCare (Nasdaq:GEHC).

Saccaro leaves Baxter at the end of May after 21 years at the company, including the past eight as CFO. He takes up the title of SVP and CFO and GE HealthCare, effective June 1, 2023.

Baxter named Brian Stevens acting CFO as it conducts a search to fill the role. Stevens joined in 2018 as SVP, chief accounting officer and controller. He continues to undertake responsibilities for those roles while acting as CFO.

“Jay has been an invaluable member of Baxter’s leadership team throughout his career,” said José (Joe) E. Almeida, Baxter chair, president, and CEO. “He’s been a true partner as CFO as we’ve worked to reposition and refocus our business. We thank Jay for all he has contributed and wish him the very best in his next role.” Read more

How device manufacturers are mitigating high-risk exposure to hospital budgets

Surgical robotics systems are among the most expensive hospital purchases. [Photo via Adobe Stock]

Medical device manufacturers face volatile equipment orders from hospitals in the next couple of years, with some more exposed to capital budget risk than others.

A new report from Moody’s Investors Service identified eight medtech companies with exposure to changes in hospital capital budgets and examined how well they mitigated that risk with recurring or noncapital sales.

This balance is an important consideration for medtech developers of all sizes as hospitals continue to face staffing and budget challenges with no relief in sight. The report also highlights the importance of innovation in overcoming macroeconomic challenges.

“With a potential recession and inflationary pressures driving up hospitals’ cost of labor, utilities and other expenses, medical device original equipmen…

Baxter to divest its BioPharma Solutions business for $4.25B

Baxter continues to streamline, announcing today that it will sell its pharma and biotech contract manufacturing business.

The Deerfield, Illinois-based medtech company — maker of diagnostic, critical care, kidney care, nutrition, hospital and surgical products and services — will sell its BioPharma Solutions (BPS) business to private equity firms Advent International and Warburg Pincus. Baxter expects the $4.25 billion sale to close in the second half of 2023, pending customary regulatory approvals and closing conditions.

After taxes, Baxter will receive roughly $3.4 billion from the deal.

“Today represents an important step in Baxter’s ongoing transformation journey as we continue to execute against our strategic priorities, enhance our focus and create additional value for all our stakeholders,” Baxter CEO José (Joe) E. Almeida said in a news release.

“BPS has long been recognized worldwide as a trusted and preferred partner of contract manufa…

Baxter to divest its BioPharma Solutions business for $4.25B

Baxter (NYSE: BAX) + continues to streamline, announcing today that it will sell its pharma and biotech contract manufacturing business.

The Deerfield, Illinois-based medtech company — maker of diagnostic, critical care, kidney care, nutrition, hospital and surgical products and services — will sell its BioPharma Solutions (BPS) business to private equity firms Advent International and Warburg Pincus. Baxter expects the $4.25 billion sale to close in the second half of 2023, pending customary regulatory approvals and closing conditions.

After taxes, Baxter will receive roughly $3.4 billion from the deal.

“Today represents an important step in Baxter’s ongoing transformation journey as we continue to execute against our strategic priorities, enhance our focus and create additional value for all our stakeholders,” Baxter CEO José (Joe) E. Almeida said in a news release.

“BPS has long been recognized worldw…

Baxter stock rises on Street-beating Q1, raised guidance

Baxter (NYSE: BAX) + shares ticked up today on first-quarter results that beat the consensus forecast.

Shares of BAX rose 3.1% to $47.50 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell 0.5%.

The Deerfield, Illinois-based medtech company posted profits of $44 million in the quarter. That amounts to 9¢ per share on sales of $3.65 billion for the three months ended March 31, 2023.

Baxter reported a 38% bottom-line slide on a sales decline of 1.6% year over year.

Adjusted to exclude one-time items, earnings per share came in at 59¢. That landed 10¢ ahead of projections on Wall Street. Sales posted a slight beat, as analysts expected revenues of $3.6 billion.

Baxter pointed to sales growing at constant currency rates (2%), reflecting positive demand across its portfolio. The company said it s…

Baxter warns over Life2000 ventilation system

The Life2000 ventilation system. [Image from Baxter/Hillrom]Baxter (NYSE:BAX) issued an urgent medical device correction for its Life2000 ventilation system due to potential oxygen desaturation.

Patient oxygen desaturation (low blood oxygen) events can occur under certain conditions. These may happen when the Life2000 system connects with a third-party oxygen concentrator.

Hillrom — acquired by Baxter for $12.5 billion in 2021 — manufactures the Life200 system.

According to an FDA notice, low oxygen saturation may lead to symptoms including shortness of breath, confusion, rapid heart rate or bluish skin. Among the most vulnerable patients, death, life-threatening events or permanent impairment may occur if caregivers don’t recognize lower oxygen levels.

Scenarios that may lead to this issue include kinked hoses or hoses with excessive moisture. Additional scenarios include extended or loose/disconnected tubing, oxygen liter flow from the concen…