Why Affera’s cardiac ablation technology is worth $1B to Medtronic

Affera’s Sphere-9 mapping and ablation catheter [Photo courtesy of Affera]

Affera started in 2014 with a simple goal that paid off when Medtronic (NYSE:MDT) bought the company for up to $1 billion this year.

Achieving that goal, however, took some unconventional and sometimes difficult design choices, Affera founder and CEO Doron Harlev said.

Newton, Massachusetts–based Affera’s system diagnoses, maps and treats heart arrhythmias with ablation. It’s a process that scars heart tissue to interrupt errant signals. Affera’s system uses both radiofrequency (RF) ablation — as well as the non-thermal pulsed-field ablation tech that has been generating buzz in medtech.

Complex arrhythmias like atrial fibrillation and ventricular tachycardia can require an electrophysiologist to perform more extensive ablation. But Harlev and his team at Affera thought a larger ablation tip could ma…

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Medtronic launches 7-day infusion set for insulin pumps in U.S.

[Image from Medtronic]Medtronic (NYSE:MDT) announced today that it launched its Medtronic Extended Infusion set for seven-day wear with insulin delivery.

The Medtronic Extended Infusion Set represents the first and only infusion set labeled for wearing of up to seven days. The infusion set for delivering insulin from a pump to the body typically requires changing every two to three days. It is available exclusively for customers using MiniMed 600 and 700 series pumps. Medtronic developed it in partnership with Convatec Infusion Care.

Get the full story at our sister site, Drug Delivery Business News.

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What’s next for Medtronic RDN after Symplicity Spyral trial ‘surprise’?

The Symplicity Spyral renal denervation system delivers energy to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]

The Medtronic (NYSE:MDT) Symplicity Spyral renal denervation (RDN) treatment’s failure to outperform hypertension drugs came as unexpected news to analysts who have been watching the industry’s efforts in the space for years.

Analysts from BTIG and Truist Securities said they have new questions about commercialization, reimbursement and physician acceptance as Medtronic seeks FDA approval for what could be a billion-dollar business.

While the Symplicity Spyral treatment for patients on blood pressure medication was demonstrated to be safe and showed a statistically significant and clinically meaningful reduction in office-based systolic blood pressure, the treatment failed to meet its primary efficacy endpoint.

“The…

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Medtronic RDN trial fails to beat hypertension drugs; data submitted for FDA review

Medtronic’s Symplicity Spyral renal denervation catheter [Image courtesy of Medtronic]Medtronic (NYSE:MDT) said its Symplicity Spyral renal denervation (RDN) system for treating hypertension failed to outperform blood pressure drugs in the latest trial results.

However, the SPYRAL HTN-ON MED clinical trial’s six-month results did show improvement over Medtronic’s previous RDN efforts, the device maker said in a news release.

RDN is designed to treat hypertension with a one-time outpatient procedure that delivers energy to the nerves in the wall of the artery leading to the kidney. Medtronic’s Symplicity Spyral catheter device delivers radiofrequency energy through four electrodes.

RELATED: What is renal denervation? Medtronic Coronary and RDN President Jason Weidman explains

Medtronic said it submitted the final module of the Symplicity Spyral Premarket Approval package to the FDA for review and approval.

The company pr…

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Acutus Medical achieves $20M milestone in Medtronic deal

Acutus Medical (Nasdaq:AFIB) announced today that it completed the first milestone under its asset purchase agreement with Medtronic (NYSE:MDT).

Carlsbad, California-based Acutus announced in April that it agreed to sell its left-heart access portfolio to Medtronic for $50 million.

It completed the first of two closings in its portfolio sale in June.

The achievement of the first milestone triggers a $20 million earnout payment from Medtronic. It allows Acutus to become an original equipment manufacturer (OEM) for Medtronic as well. Acutus plans to continue selling its left-heart access portfolio until its commercial distribution transitions to Medtronic.

“We are very pleased with the partnership we have built with Medtronic, with both teams working diligently to ensure a smooth transition for all stakeholders. We are excited about the potential to accelerate this innovative product line’s impact on patient care with Medtronic’s global reach, and w…

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Titan Medical CEO sees ‘unique opportunity’ for Enos surgical robot in an increasingly crowded field

Titan Medical CEO Cary Vance [Photo from Vance’s LinkedIn page] Titan Medical CEO Cary Vance discusses the Enos robotic surgery platform, deals with Medtronic and supply chain silver linings.

Titan Medical President and CEO Cary Vance said he knew what he was getting into when he was approached about leading the robotic surgery company.

“The challenges, I knew what they were,” said Vance, who had served on the company’s board for two years when he became CEO of Titan in July. “I knew the opportunity we had to meet those challenges and knew the people I’d be working with … could make sure whatever strategy we have is executed.”

Vance sees “a unique opportunity” ahead of Toronto-based Titan, which is manufacturing the Enos surgical robot platform with plans to enter into clinical use next year.

In June, Titan delayed its FDA investigational device exemption (IDE) submission timeline for the roboti…

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Health Canada licenses Medtronic next-gen MiniMed 780G insulin pump

The next-gen MiniMed 780G system. [Image from Medtronic]Medtronic (NYSE:MDT) Canada announced today that Health Canada granted a license to its MiniMed 780G automated insulin delivery system.

The company designed its MiniMed 780G advanced hybrid closed-loop insulin pump system to automatically adjust and correct sugars every five minutes. According to Medtronic, it marks the first and only insulin pump system in Canada to do so. It also features SmartGuard technology for avoiding highs and lows in blood sugar.

SmartGuard enables users to personalize their glucose goals with an adjustable target setting. The setting — as low as 5.5 mmol/L — comes in lower than any other advanced hybrid closed-loop system, Medtronic said. It helps stabilize blood sugar levels to further improve glucose control.

Get the full story at our sister site, Drug Delivery Business News.

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Medtronic study highlights need for standardized post-stroke pathways

Medtronic (NYSE:MDT) today announced results from a study of post-stroke workflow protocols and cardiac monitoring.

The DiVERT Stroke clinical study demonstrated that the protocols and monitoring vary significantly across community hospitals and academic centers. Medtronic presented data today at the 14th World Stroke Congress in Singapore.

Medtronic’s first-of-its-kind, multi-center study evaluated more than 7,600 cryptogenic, large-artery and small-vessel stroke patients. It took place across 12 hospitals in the U.S. The study found more than 75% of cryptogenic stroke patients at large academic centers received some form of cardiac monitoring. This includes external cardiac monitors and implantable loop recorders.

Conversely, 5% of cryptogenic stroke patients received such monitoring at community hospitals.

Better stroke prevention and treatment tech is a priority for Medtronic. Last week, at our DeviceTalks West event in Santa Clara, Cali…

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October 2022 Issue: Women in Medtech

Rachel Ellingson is driving Zimmer Biomet toward new tech

What Laura Mauri learned from a ‘firestorm’ in her first months at Medtronic

How Medline maintains quality while innovating and growing

How a wrist-worn device treats essential tremor

Diversity in medtech: 2022 markedly the best for women in medtech

Diverse executive teams bring more innovation to medtech Diversifying the executive suite is more than just a push for representation — it helps bring more diverse ideas to the table to innovate for more than half of the global population.

The leadership gap in the medical device industry closes slightly every year, but women still account for less than a quarter of executive roles, according to our annual analysis in this Women in Medtech edition of Medical Design & Outsourcing.

Women hold just 23% of executive roles at the top 100 medical device companies, up 2 percentage points since 2021. After Accuray and Ambu appointed f…

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How Medtronic, Abbott, Resmed see healthcare improving through ecosystems

Medtronic’s Geoff Martha (left), Abbott’s Lisa Earnhardt (middle) and ResMed’s Mick Farrell (right). The trio discussed the medtech ecosystem at AdvaMed’s The MedTech Conference in Boston.

According to McKinsey & Company Senior Partner Rajesh Parekh, “ecosystem” is a word used plenty in the tech world. Now it’s coming into the medtech space.

So, what is an ecosystem? How can medtech companies take advantage of one to provide better care and improved patient outcomes? How can they do so with speed in an ever-changing environment? Three major medtech leaders joined Parekh at AdvaMed’s The MedTech Conference in Boston to try and explain that.

Medtronic Chair and CEO Geoff Martha, Abbott EVP of Medical Devices Lisa Earnhardt and ResMed CEO Mick Farrell offered their views on ecosystems in the space.

What is an ecosystem in healthcare?

Earnhardt said an ecosystem brings a variety of stakeholders together to …

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Medtronic installs first GI Genius modules in Twin Cities

Medtronic’s GI Genius intelligent endoscopy module [Image courtesy of Medtronic]Medtronic (NYSE:MDT) announced that it completed the installation of 28 GI Genius intelligent endoscopy modules in Minnesota.

Fridley, Minnesota-based Medtronic installed the intelligent endoscopy modules at seven MNGI Digestive Health Clinics in the Twin Cities. MNGI Digestive Health specializes in gastrointestinal care.

According to a news release, the installations make MNGI the first practice offering AI-assisted colonoscopies in the Twin Cities. This includes those for colorectal cancer screening.

“We know the value of an AI-assisted colonoscopy,” said Bob White, EVP and president of the Medical Surgical Portfolio for Medtronic. “I’m proud that Minnesotans will now join other patients across the country who have access to this life-transforming technology and proven polyp detection tool. Nationwide, over 51,000 individuals died from colorectal cancer in 2019; we are working…

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What does the future hold for AI in medical devices?

(Image courtesy of the FDA)

Digital health, artificial intelligence (AI), machine learning and more — these concepts continue to generate buzz in the medtech world.

Last month, the FDA published guidance on clinical decision support (CDS) software. It helped to clear up what constitutes a medical device and what doesn’t. Early last year, the agency published a predetermined change control plan (PCCP) to help build a regulatory structure for such technology.

These topics and more spurred intriguing commentary on a panel at AdvaMed’s MedTech Conference in Boston today.

The panel featured viewpoints across all angles of the space. Dr. Yuri Maricich, CMO and head of development at Pear Therapeutics, offered thoughts from the developer of digital therapeutics. Brendan O’Leary, acting director of the Digital Health Center of Excellence at the FDA, provided the regulatory vantage point.

Cybil Roehrenbeck, a partner at Hogan Lovells, off…

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