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MedTech 100 roundup: Industry reaches another high point

The medtech industry is continuing its massive 2021 boom, with the past week marking yet another record in the markets.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (Aug. 27) at 121.05 points, representing a 1.2% rise from the 119.63-point mark set a week before. Following a slight dip earlier this month, the industry continues to tick up to new heights.

Medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry remains well above the marks set around the height of the pandemic, having registered a 31.1% increase from the pre-pandemic high of 92.32 (set on Feb. 19, 2020). Moreover, it remains well ahead of the mid-pandemic low of 62.13 (March 23, 2020) as well, totaling a 94.8% ascent above that point.

The industry’s performance fell in line with the overall markets this past week as the S&P 500 I…

Medtronic touts real-world data for Micra leadless pacemaker

The next-gen Micra AV is the size of a large vitamin pill — the same as its predecessor. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) today touted data demonstrating reductions in reinterventions and complications with its Micra pacemaker.

Fridley, Minn.-based Medtronic’s Micra Coverage with Evidence Development (CED) study, which it labeled the largest evaluation of leadless pacemakers to date, showed that the Micra transcatheter pacing system (TPS) was associated with a 38% reduction in reinterventions and a 31% reduction in chronic complications at two years when compared with traditional transvenous pacemakers.

The company presented data virtually in a late-breaking trials presentation at the European Society of Cardiology (ESC) Congress 2021, according to a news release.

Micra TPS, a leadless pacemaker option for patients who only require pacing in the right ventricle, represents an option that is comparable in size to a large vitamin, falli…

Medtronic CEO Geoff Martha touts progress on renal denervation and Hugo robotics

Medtronic CEO Geoff Martha

Medtronic (NYSE: MDT) is boosting its research and development spending in fiscal year 2022 by more than 10 percent, which CEO Geoff Martha described as the largest dollar increase ever for the Fridley, Minn.-based medical device manufacturer.

“The investments we’re making in our pipeline will play a key role in accelerating our top-line growth, and we’re at the front end of some large opportunities to win share, create new markets and disrupt existing markets,” he said in a quarterly earnings call with investors and analysts this week.

Topping Medtronic’s list of golden opportunities are its renal denervation treatment for hypertension and its Hugo soft tissue robotic-assisted surgery system, two areas where Medtronic executives see multibillion-dollar businesses.

Medtronic’s investments in Hugo and renal denervation are expected to cost $400 milli…

FDA approves Medtronic next-gen Evolut FX TAVR system

Medtronic today announced that its Evolut FX TAVR system has won FDA approval.

Fridley, Minn.-based Medtronic designed the self-expanding transcatheter aortic valve replacement system to treat symptomatic severe aortic stenosis.

Get the full story on our sister site, Medical Tubing + Extrusion.

Medtronic beats The Street on 23% sales growth in Q1

Medtronic (NYSE:MDT) posted first-quarter results today that beat the overall consensus on Wall Street and reiterated its full-year guidance.

The Fridley, Minn.-based company reported profits of $769 million, or 56¢ per share, on sales of $7.98 billion for the three months ended July 30, for a bottom-line gain of 56.6% on sales growth of 22.74% compared with Q1 2021.

Adjusted to exclude one-time items, earnings per share were $1.41, 9¢ ahead of The Street, where analysts were looking for sales of $7.86 billion.

“Fiscal 2022 is off to a strong start with our first-quarter results coming in ahead of our expectations, reflecting solid execution and continued procedure volume recovery, with most of our businesses at or above pre-COVID levels,” CEO Geoff Martha said in a news release. “In addition, we drove market share gains across a number of our businesses, including three of our largest: cardiac rhythm management, surgical innovations, and cranial & s…

How Medtronic fit a battery into a tiny pacemaker

Medtronic’s Micra pacemakers are one-tenth the size of what was previously out there. How the medtech giant did it provides lessons for anyone looking to shrink an implantable device. The next-gen Micra AV is the size of a large vitamin pill — the same as its predecessor. [Image courtesy of Medtronic]It was an all-hands-on-deck effort that consumed Medtronic in the early 2010s: the in-house creation of a pacemaker small enough to go inside the heart via a catheter.

The tiny pacemaker could be a game-changer because it would do away with connecting wires to the heart — a major source of complications. To get there, though, the Medtronic development team had to solve significant challenges involving battery life and energy use. How could they create a pacemaker that was roughly one-tenth the size of a traditional pacemaker but still last at least seven years inside someone?

“It would be like taking your car and reducing the size of the tank by a factor o…

How Medtronic fit a battery into a tiny pacemaker

Medtronic’s Micra pacemakers are one-tenth the size of what was previously out there. How the medtech giant did it provides lessons for anyone looking to shrink an implantable device.

The next-gen Micra AV is the size of a large vitamin pill — the same as its predecessor. [Image courtesy of Medtronic]

It was an all-hands-on-deck effort that consumed Medtronic in the early 2010s: the in-house creation of a pacemaker small enough to go inside the heart via a catheter.

The tiny pacemaker could be a game-changer because it would do away with connecting wires to the heart — a major source of complications. To get there, though, the Medtronic development team had to solve significant challenges involving battery life and energy use. How could they create a pacemaker that was roughly one-tenth the size of a traditional pacemaker but still last at least seven years inside someone?

“It would be like t…

ProPublica report raises questions about FDA’s handling of Medtronic’s HVAD

Medtronic’s HVAD [Image courtesy of Medtronic]A recent ProPublica report highlighted potential failings by the FDA in the handling of Medtronic’s HVAD system.

In June, Medtronic stopped distributing and selling its HeartWare Ventricular Assist Device (HVAD) system amid a slew of clinical comparisons indicating a higher frequency of neurological adverse events, including stroke and mortality, with the HVAD system. The company had previously recalled the device after 855 complaints and eight injuries related to an issue with the device’s ports in February. Medtronic reported 12 deaths among implanted patients in that recall, although three weren’t related to the particular issue at hand.

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

ProPublica report raises questions about FDA’s handling of Medtronic’s HVAD

A recent ProPublica report highlighted potential failings by the FDA in the handling of Medtronic’s HVAD system.

In June, Medtronic stopped distributing and selling its HeartWare Ventricular Assist Device (HVAD) system amid a slew of clinical comparisons indicating a higher frequency of neurological adverse events, including stroke and mortality, with the HVAD system. The company had previously recalled the device after 855 complaints and eight injuries related to an issue with the device’s ports in February. Medtronic reported 12 deaths among implanted patients in that recall, although three weren’t related to the particular issue at hand.

Along with Medtronic’s announcement that it would cease the distribution of its HVAD system, the FDA issued a statement alerting providers to no longer implant the HVAD, with the administration stating that it was working closely with Medtronic to “ensure patient care is optimized” as the device was taken off the…

MedTech 100 roundup: Industry ticks up again

The medtech industry has been rising for weeks and the latest seven-day stretch was no exception as stocks ticked up again.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (Aug. 6) at 119.41 points, marking a 0.5% rise from the previous week’s tally of 118.86 points (July 30). Not including the the week in which the index shot up to 145.88 points and quickly tumbled down, the latest marks would represent the index’s all-time best.

Medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry has registered a 29.3% increase from the pre-pandemic high of 92.32 (set on Feb. 19, 2020). Moreover, it remains well ahead of the mid-pandemic low of 62.13 (March 23, 2020) as well, totaling a 92.2% ascent above that point.

The industry’s performance did not correlate with the overall markets this past week as t…

Medtronic acquires Intersect ENT in $1.1B deal

Medtronic (NYSE:MDT) today announced that it has entered a definitive agreement to acquire Intersect ENT (NSDQ:XENT) for $1.1 billion.

Medtronic will acquire all outstanding shares of Menlo Park, Calif.-based Intersect ENT for $28.25 per share in an all-cash transaction for an enterprise value of approximately $1.1 billion.

The acquisition will expand Medtronic’s portfolio of ear, nose and throat medical devices. Intersect ENT makes the Propel and Sinuva sinus implants that open sinus passageways to deliver an anti-inflammatory steroid to aid in healing.

Intersect ENT launched its VenSure balloon sinus dilation system in the U.S. in late July and won regulatory approvals for its Propel Contour sinus implant in May.

“This acquisition directly aligns with our commitment to delivering continuous innovation that helps ENT patients,” Vince Racano, president of Medtronic’s ENT business, said in a news release. “Intersect EN…

FDA clears Medtronic’s AI algorithms for cardiac monitoring

Medtronic (NYSE:MDT) announced today that the FDA cleared two of its AccuRhythm AI algorithms for use with the Linq II ICM.

Fridley, Minn.-based Medtronic’s AccuRhythm AI applies artificial intelligence to heart rhythm event data collected by the Linq II insertable cardiac monitor (ICM) in an effort to improve the information provided to physicians for better diagnoses and treatments for abnormal heart rhythms, according to a news release.

The company will present data on the AccuRhythm algorithms for the Linq II ICM at Heart Rhythm 2021 this week.

Medtronic said the now-cleared, cloud-based AccuRhythm algorithms address the two most common ICM false alerts: Afib and asystole. The Afib algorithm reduced false alerts by 74.1% and preserved 99.3% of true Afib alerts, the company noted, while the “pause” algorithm for asystole reduced false pause alerts by 97.4% and preserved 100% of true pause alerts.

“Applying AccuRhythm AI …