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Ancora Heart raises $80M for ventricular restoration system

Ancora Heart announced today that it raised $80 million in equity financing for its AccuCinch ventricular restoration system.

Santa Clara, Calif.-based Ancora Heart said in a news release that funds raised in the equity round are earmarked for the acceleration of the Corcinch-HF pivotal clinical study of the AccuCinch system for treating symptomatic heart failure with reduced ejection fraction (HFrEF).

The company won FDA investigational device exemption for AccuCinch in June 2020 and began enrolling patients in the pivotal trial in January of this year.

Ancora Heart designed AccuCinch to treat patients with HFrEF by directly reshaping the left ventricle of the heart to address the fundamental issue in the progression of systolic heart failure. The company touts it as the only completely transcatheter procedure for treating the enlarged left ventricle.

Sands Capital, Sio Capital and an undisclosed strategic investor joined all existing investors f…

FDA approves Nevro spinal cord stimulation to treat chronic pain with diabetic neuropathy

The Senza system [image from Nevro]Nevro (NYSE:NVRO) announced today that it received FDA approval for its Senza system for treating chronic pain associated with PDN.

Redwood City, Calif.-based Nevro’s Senza system’s approval is specific to Nevro’s 10 kHz stimulation, with the company touting that it now has the only spinal cord stimulation system approved by the FDA with a specific indication for treating PDN (painful diabetic neuropathy).

FDA approval follows the published results of the SENZA-PDN trial in JAMA Neurology, which demonstrated the safety and efficacy of the spinal cord stimulation (SCS) system.

In April, Nevro touted results from the randomized SENZA-PDN trial, which met its prespecified primary endpoint by demonstrating that PDN patients with symptoms refractory to best available treatments can be safely and effectively treated with high-frequency (10 kHz) SCS, Nevro said. The trial pitted Senza, plus conventional medical …

Endologix wins FDA breakthrough nod for aneurysm sealing system

[Image from Endologix]Endologix announced today that the FDA granted breakthrough device designation for its Chimney endovascular aneurysm sealing system (Chevas).

Irvine, Calif.-based Endologix designed its Chevas system as an investigational endovascular abdominal aortic aneurysm (AAA) sealing therapy that combines the Nellix 3.5 endograft with parallel visceral stents to treat patients with juxtarenal, pararenal and suprarenal AAA, according to a news release.

The company is currently evaluating the Chevas system through the Chevas One investigational device exemption (IDE) clinical study, set to enroll approximately 120 patients across up to 50 clinical sites around the world.

Dr. Francis Caputo (Cleveland Clinic Foundation), Dr. William Jordan (Emory University School of Medicine), Dr. Joseph Lombardi (Cooper University Health Care) and Dr. William Quinones-Baldrich (UCLA) are the national principal investigators for the study.

The study’s…

Dexcom CEO Kevin Sayer says G7 will be ‘wonderful’

As we enter what may be the “new normal,” Dexcom’s CEO bets the company can pave the way in continuous glucose monitoring.

Dexcom (NSDQ:DXCM), like any company seeking to innovate, remains in a state of perpetual forward motion.

That’s the way chair, president & CEO Kevin Sayer views it, anyway. As the company looks toward the future, the G7 continuous glucose monitor is the next big thing.

San Diego–based Dexcom’s latest iteration of its CGM system — building on the G6, which first won FDA approval in 2018 — has inspired plenty of optimism, both within the ranks of Dexcom and likely among customers, too.

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

MedTech 100 roundup: Industry shatters all-time best with remarkable rise

The medtech industry’s steady growth provided optimism in recent weeks, but an unforeseen leap sees it hitting new heights now.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week (July 16) at 145.88 points, a remarkable 27.1% rise week-over-week, registering by far the greatest increase the index has seen since its inception.

Remarkably, the industry’s July 9 tally of 114.79 points a week prior had, at that point, been known to be the index’s all-time best to date. The new high set on Friday of last week totals an increase of 31.09 points.

Medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too, especially after this latest unpredictable rise. The industry has registered a 58% increase from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus it has fully eclipsed 100% growth from the mid-pand…

Pfizer, subsidiaries agree to pay $345M in EpiPen pricing lawsuit

Pfizer (NYSE:PFE) agreed to pay $345 million to settle claims of overpayments for EpiPens due to alleged anti-competitive and unfair practices.

Reuters reported that a filing disclosed in federal court in Kansas City, Kan., revealed the settlement set to resolve claims from consumers who say they overpaid for EpiPens with the alleged anti-competitive and unfair practices by Pfizer and its Mylan subsidiary, which markets the EpiPen.

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

FDA clears Dexcom Partner Web APIs

Dexcom (NSDQ:DXCM) announced today that it received FDA clearance for its Dexcom Partner Web application programming interfaces (APIs).

The San Diego-based company’s Dexcom Partner Web APIs enable invited third-party developers to integrate real-time continuous glucose monitoring (CGM) data into their digital health apps and devices.

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

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…

7 ways to ensure your medical device product design isn’t biased

Correcting unintentional biases in medical device product design is a big step toward improving equity in medtech.

[Image from Pixabay]Achuta Kadambi, an assistant professor at the UCLA Samueli School of Engineering, says when looking at bias in medical devices, there’s often a lot of narrative in the media of what it is. However, it’s also important to address what it doesn’t show.

“One that doesn’t show up is that it’s a really challenging technical problem and an exciting technical problem to address,” he said, citing an example of how light doesn’t play well with darker objects like darker skin tones.

Kadambi, who recently published a column in the journal Science about achieving fairness in medical devices, says there has to be a technical passion for solving these problems. (He also discussed his views during a recent DeviceTalks Weekly podcast.)

He adds that the social impact is equally crucial …

HeartFlow to go public in $2.8B SPAC merger

HeartFlow today said that it will go public by merging with a SPAC called Longview Acquisition Corp.

The merger is valued at $2.4 billion with an estimated $400 million in cash after closing. The transaction is expected to deliver up to $599 million of gross proceeds to HeartFlow to accelerate the growth of its noninvasive, personalized cardiac tests.

“We believe that our non-invasive, artificial intelligence-enabled, cloud-based enterprise software solution can transform cardiovascular care with risk assessment, diagnosis planning and treatment management,” HeartFlow president, CEO and cofounder John Stevens said in a news release. “Importantly, we have brought together a talented group of individuals with deep expertise in technology, cardiovascular medicine, and the business of healthcare and a deep commitment to patients to deliver on this vision. I’m incredibly proud of the HeartFlow team in reaching this important milestone.”

Through the deal, the …

Vivasure Medical initiates development of sutureless venous closure device

Vivasure Medical announced today that it launched a development program for its PerQseal Blue investigational product.

Galway, Ireland-based Vivasure designed PerQseal Blue for sutureless and fully absorbable large-bore venous vessel closure following percutaneous cardiovascular procedures, including transcatheter mitral valve repair/replacement (TMVR) and transcatheter tricuspid valve repair/replacement (TTVR).

According to a news release, the company based the PerQseal Blue on its PerQseal closure device that currently holds European approval for use in femoral arteries.

The newly initiated development program was first initiated in 2020 with a €2.5 million grant from the European Innovation Council Accelerator. Vivasure said that no sutureless options for venus closure after TMVR or TTVR procedures currently exist, which would make PerQseal Blue the first.

PerQseal Blue consists of an intravascular patch designed to seal the vessel from the ins…

Imperative Care raises $260M Series D for stroke care tech, acquires Truvic Medical

Imperative Care announced today that it closed a $260 million Series D financing round to support its stroke care technologies.

Campbell, Calif.-based Imperative Care had its funding led by D1 Capital Partners, with new investors HealthCor Investments and Innovatus Capital Partners also joining the round. Existing investors Ally Bridge Group, Bain Capital Life Sciences, Ascension Ventures, Delos Capital, Rock Springs Capital and Amed Ventures participated.

As a result of the financing, James Rogers of D1 Capital Partners will join Imperative Care’s board of directors, according to a news release.

The company said it earmarked proceeds from the financing for the support of the ongoing commercialization and development efforts across its portfolio of stroke care technologies. Additionally, funds will be used to create a strategic network of wholly-owned development subsidiaries in a range of areas.

“We are grateful for the confidence our inves…