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Abbott completes $890M acquisition of Cardiovascular Systems

Abbott (NYSE:ABT) + announced today that it completed its acquisition of Cardiovascular Systems.

In February, Abbott announced its agreement to acquire the atherectomy technology developer. Abbott agreed to pay $20 per common share of Cardiovascular Systems, leading to a total expected equity value of about $890 million.

Cardiovascular Systems develops the Diamondback 360 system for atherectomy in treating peripheral and coronary artery disease. The minimally invasive procedure cuts plaque from the walls of a blood vessel. Healthcare professionals use it in addition to or as an alternative to balloon angioplasty. The system prepares vessels for angioplasty or stenting to restore blood flow.

Abbott said in a news release that the acquisition provides the company with a complementary solution for treating vascular disease. The company develops its own angioplasty solutions and stents.

Pursuant to the terms o…

Medtech tackles environmental, social and governance challenges

[Image from Unsplash]

The medical device industry, in recent years, has increasingly faced environmental, social and governance challenges.

As in other cases, challenges can also present opportunities. Here’s what you could discover at DeviceTalks Boston, which runs May 10–11. (Register here!)

Sustainability for environmental benefit

Medical devices can produce a profoundly positive effect on individuals needing care, but they’re also an environmental problem because they create enormous pressure on waste streams once they’re outdated and discarded.

Opportunity: Medical device makers can avoid this growing catastrophe by building sustainability into their designs. In two different sessions, leaders Canon Virginia, Gradian Health Systems and Sagentia Innovation will examine how medical devices can be made with a view toward global health.

Healthcare equity

How can we ensure life-…

AI in drug development: Janssen exploring potential of AI in everything from target discovery to clinical trials

As enterprise AI adoption surges, the life science industry stands at a pivotal juncture. “We are truly at a tipping point,” remarked Najat Khan, chief data science officer at Janssen, during the 2023 Stanford Drug Discovery Symposium. “It’s amazing how quickly we’ve been able to make progress across the whole value chain in terms of drug development,” she said. “The reality is that there’s a lot of hype, but there is already a lot that’s happening.”

While most Big Pharma companies are exploring AI applications, as a 2022 Clinical Trials Arena article noted. It’s easy to understand why. While developing a given drug might take more than a decade, AI could potentially enable the development of “drugs in one-tenth of the time, from being discovered to being able to treat patients,” wrote McKinsey partner Alex Deverson in late 2022.

Janssen is aiming to distinguish itself by building a team of “bilingual”…

ZimVie opens state-of-the-art dental training facility in Florida

[Image courtesy of ZimVie]ZimVie (Nasdaq:ZIMV) announced today that it opened a new, state-of-the-art educational facility for dental practitioners.

Westminster, Colorado-based ZimVie built its facility in Palm Beach Gardens, Florida. The “ZimVie Institute South” features more than 11,000 square feet of dedicated education and training space. It offers life-like simulated patient models, a cadaver lab and a fully integrated digital workflow.

ZimVie, the Zimmer Biomet dental and spine spinoff, said the facility also has 3D printing capabilities, RealGuide software and a mill.

According to a news release, the facility expands its institute model to enable the company to host cadaver and simulation courses. These courses teach advanced surgical and restorative techniques for full mouth reconstructions. The institute also hosts comprehensive training events covering everything from practice management to digital workflow training.

Located at …

FDA clears Veraflo therapy dressings from 3M

The Veraflo Cleanse Choice Complete dressing and V.A.C. Veraflo Cleanse Choice dressing. [Image courtesy of 3M]3M (NYSE:MMM) announced today that it received FDA clearances for its Veraflo therapy with two different dressings.

The clearances cover the Veraflo Cleanse Choice Complete dressing and V.A.C. Veraflo Cleanse Choice dressing. 3M said they received the first-ever FDA clearance for hydromechanical removal of infectious materials, non-viable tissue and wound debris. This reduces the number of surgical debridements required. It also promotes granulation tissue formation, creating an environment that promotes wound healing.

“Veraflo Therapy gives wound care clinicians a proven tool to facilitate healing and reduce the need for surgical intervention,” said Dr. Ronald Silverman, 3M Health Care SVP of clinical affairs and chief medical officer. “This FDA clearance highlights 3M innovation at its best – using science to help improve patient outc…

Nevro enrolls first patient in PDN Sensory study

Nevro this week announced it enrolled the first patient in its painful diabetic neuropathy (PDN) sensory study.

The prospective randomized controlled trial will assess the restoration of neurological function as a primary objective in patients with intractable PDN. It will enroll up to 236 patients at multiple sites across the U.S.

Patients in the trial will be randomized to conventional medical management or 10 kHz Therapy, along with conventional medical management with optional crossover to the other treatment arm at 6 months if the criteria are met.

The FDA previously granted breakthrough device designation for the study and the potential device indication. The FDA’s designation enables Nevro to receive a quicker review for its marketing application, which seeks to broaden its FDA labeling. This will give patients and healthcare providers faster access to vital medical devices that can provide improved treatment or diagnosis of serious, irrever…

Dexcom G6 picks up coverage expansion in Canada

The Dexcom G6. [Image courtesy of Dexcom]Dexcom (Nasdaq:DXCM) today said it applauds an expansion of coverage for continuous glucose monitoring (CGM) systems in Canada.

The coverage expansion comes through the Non-Insured Health Benefits (NIHB) program. It now enables any client managing diabetes with insulin to access the standard of care.

Dexcom said its G6 CGM is now at its most accessible point ever under the NIHB program. It marks the highest degree of diabetes management possible for First Nations and Inuit peoples. According to the company, the expansion brings people in Canada one step closer to accessing the technology they need.

This expansion in Canada follows a major Medicare coverage win in the U.S. for Dexcom and CGM makers alike. Earlier this year, the company had another Canadian coverage win, too. Dexcom said in March that all people with type 1 and type 2 diabetes in Manitoba, Canada, meet eligibility criteria for its G6 CGM.

Innoblative Designs wins FDA breakthrough nod for ablation device

The SIRA RFA electrosurgical ablation device. [Image courtesy of Innoblative Designs]Innoblative Designs announced today that it received FDA breakthrough device designation for its SIRA RFA electrosurgical device.

Chicago-based Innoblative Designs designed SIRA for use in breast cancer patients undergoing BCS (lumpectomy). The company plans to present data supporting its breakthrough nod this week. It’s presenting at the Annual Meeting for The American Society of Breast Surgeons in Boston.

“The SIRA technology is an exciting advancement in the treatment of breast cancer as it is designed to allow surgeons to address potential residual cancer in the lumpectomy cavity at the time of the initial procedure,” said Dr. Thomas Frazier, medical director, Comprehensive Breast Center at Bryn Mawr Hospital in Pennsylvania. “Designed to augment the lumpectomy procedure, the SIRA device aims to reduce the need for reoperations.”

SIRA uses …

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…

Fast Five: Medtronic remediates FDA warning letter, Boston Scientific nearly triples profits in Q1

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, April 26, 2023.

Fast Five by MassDevice · Medtronic remediates FDA warning letter, Boston Scientific nearly triples profits in Q1

Patients with diabetes rely on certain devices for their daily management, and it is vital that they have confidence in the safety and effectiveness of their products. On today’s episode, Hosts Danielle Kirsh and Sean Whooley detail how medtech giant Medtronic resolved its earlier FDA warning letter related to its diabetes business.

GE Healthcare recently launched its next-generation intraoperative ultrasound technology, a significant advancement in medical imaging. Whooley discusses how the technology could streamline physician workflow in the operating room.

Non-invasive biometric monitoring is on the horizon. Fast F…

Edwards beats The Street in Q1, raises 2023 guidance to up to 12% sales growth

Edwards Lifesciences (NYSE: EW) + shares dipped despite first-quarter results that topped the consensus forecast.

Shares of EW were down slightly to $86.72 apiece by the close of trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day up slightly.

The Irvine, California–based medical device maker yesterday evening posted profits of $340.5 million. That amounts to 56¢ per share on sales of $1.46 billion for the three months ended March 31, 2023.

Edwards posted an 8.9% bottom-line slide on sales growth of 8.8%. The company attributed the reduction in profits to a less favorable impact from foreign exchange. TAVR sales grew 8% to $948 million, while Edwards’ structural heart revenues grew by 12%. Critical care sales ticked up 5%.

The company noted that overall valve surgery growth came in higher than expected.<…

Noah Medical reports positive data for surgical robot

The Galaxy System. [Image courtesy of Noah Medical]Noah Medical today announced positive accuracy results from a study of its Galaxy System surgical robot platform.

San Carlos, California-based Noah Medical designed Galaxy and its accessories to provide bronchoscopic visualization and access. These capabilities provide diagnostic and therapeutic procedures in patient airways.

The system features advanced imaging technologies that provide real-time location updates for potentially cancerous lesions. Noah said in a news release that it designed the technology to improve tool-in-lesion and diagnostic yield.

Galaxy received FDA clearance in March of this year. Last week, Noah Medical raised $150 million to support its surgical robot platform.

The MATCH study tested the “tool-in-lesion” accuracy of the Galaxy System. Noah Medical published results for review in the Journal of Bronchology & Interventional Pulmonology.

About the results …