Medical Tubing and Extrusion

Medical tubing and extrusion technologies

Catheter-based innovations we can’t stop thinking about

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[Image courtesy of Mathew Schwartz on Unsplash]
Catheter-based devices had their year in 2023. Medtech companies set their sights on improving patient care in cardiology, neurology and more.

Our previous roundup of the top 10 most-read catheter-based news stories of 2023 wasn’t enough for us. Medical Tubing + Extrusion‘s editors could not stop thinking about several other stories when considering the medical device innovations of the year.

It was a year of many firsts for some companies. For example, Recor Medical was the first company to win FDA approval for renal denervation, and Medtronic was the first to win FDA approval for pulsed-field ablation – both treatment options that we’ve set our sights on for the last few years. While readers were interested in cardiology-based catheter-based innovations, we thought many more critical applications should not be missed.

The editorial team at Medical Tubing + Extrusion drew on its resources and knowledge of the news coverage in the industry to create this roundup of catheter-based stories that we thought were most impactful in medtech this year. From technology that treats chronic limb-threatening ischemia to the first pulsed-field ablation approval in the U.S., here are some of the top news stories our editors can’t stop thinking about, in no particular order.

This ReCor Medical illustration shows how its Paradise renal denervation catheter system works.
This ReCor Medical illustration shows the Paradise renal denervation catheter during the procedure. The red circle indicates ultrasound-generated energy producing heat for denervation, while the blue circles illustrate cooling from circulating water within the artery to protect the artery from heat. [Image courtesy of ReCor Medical]

Recor Medical wins first FDA nod for renal denervation to treat hypertension

November 8, 2023 | By Sean Whooley

Recor Medical announced that the FDA approved its Paradise ultrasound renal denervation (RDN) system for treating hypertension.

The long-awaited approval for the Otsuka Medical Devices portfolio company allows for the use of Paradise as an adjunctive treatment option when lifestyle changes and medications fail to adequately control a patient’s blood pressure.

Paradise had looked the most likely system to win approval in the race for the first FDA nod to use RDN to treat hypertension. An FDA panel voted in favor of FDA approving Paradise uRDN system in August. The same panel voted against recommending Recor’s closest competition, Medtronic’s Symplicity Spyral, a day later.

Read more about Recor’s FDA nod

What our editors are saying

Major medical device manufacturers have been trying to crack the RDN nut for more than a decade, hoping to help hundreds of millions of hypertension patients — and be first to a market estimated to be worth billions of dollars. ‘Getting a renal denervation therapy to market is one of the biggest wins that the world of devices has seen in a really long time,’ Recor Medical CEO Lara Barghout said in an interview with Medical Design & Outsourcing.Managing Editor Jim Hammerand
This technology was the first of its kind to treat a prevalent heart condition that can typically be challenging to address. Alternative options for treating hypertension are pivotal for improving the quality of life of patients.Senior Editor Danielle Kirsh
Medtronic's Symplicity Spyral device is a multi-electrode catheter for renal denervation.
Medtronic’s Symplicity Spyral device is a multi-electrode catheter for renal denervation. [Image courtesy of Medtronic]

FDA approves Medtronic’s Symplicity Spyral renal denervation system

November 17, 2023 | By Jim Hammerand

Medtronic announced FDA approval of its Symplicity Spyral renal denervation (RDN) system for treating hypertension.

A Medtronic spokesperson said the device developer received word from regulators Friday evening. Medtronic is now the second company with premarket approval (PMA) to market an RDN system for hypertension in the U.S., following Recor Medical’s approval earlier this month.

Medtronic said it plans to immediately commercialize its system and the Symplicity blood pressure procedure.

Read more about the FDA approval

What our editors are saying

Though Medtronic’s Symplicity Spyral wasn’t first across the RDN finish line, the world’s largest device developer overcame questionable odds to win FDA approval and not only walked away with a marketable system, but valuable lessons for other technologies and trials to come in the years ahead.Managing Editor Jim Hammerand
Renal denervation was a long haul for Medtronic, but they aren’t resting on their laurels after this regulatory win. They’re already considering additional uses, including the potential for Symplicity Spyral tech to help AFib patients when paired with cryoablation.Executive Editor Chris Newmarker
An image of the Medtronic PulseSelect Pulsed Field Ablation (PFA) System's catheter.
The Medtronic PulseSelect Pulsed Field Ablation (PFA) System is designed to treat paroxysmal and persistent atrial fibrillation (AFIb). [Image courtesy of Medtronic]

Medtronic PulseSelect pulsed field ablation wins FDA approval

December 13, 2023 | By Jim Hammerand

The FDA has approved the Medtronic PulseSelect pulsed field ablation (PFA) system, the device developer said today.

PulseSelect is the first PFA technology approved for use in the U.S., as well as the first PFA technology with FDA breakthrough designation to win approval.

The minimally invasive, cardiac ablation system is indicated for the treatment of paroxysmal and persistent atrial fibrillation (AFIb).

Medtronic said it will start commercialization in early 2024.

Read more about the approval

What our editors are saying

Pulsed field ablation builds on other minimally invasive cardiac ablation therapies, but has less risk of causing collateral damage because it’s a nonthermal energy. Medtronic’s system — along with competing technology from Boston Scientific that has yet to be approved — won FDA breakthrough device designation for its potential to more effectively treat AFib, which can lead to serious and fatal cardiac events.Managing Editor Jim Hammerand
Pulsed-field ablation (PFA) has been a high-excitement market for the past few years, with a number of major medtech players making strides to bring the catheter-based treatment to market. Medtronic and its PulseSelect system got a leg up on competition when the FDA approved for the treatment of AFib it in December, making it the first PFA technology approved for use in the U.S., as well as the first PFA technology with FDA breakthrough designation to win approval.Associate Editor Sean Whooley
PFA felt like a buzzword phrase for a few years, but 2023 was the year for PFA innovation. Medtronic may have won FDA approval first, but many other companies are in the space and entering the race. Smaller companies like Pulse Biosciences and larger medtech companies like Boston Scientific and J&J’s Biosense Webster want a piece of the PFA market, too. It’s an interesting technology. Senior Editor Danielle Kirsh
The Endolumik Gastric Calibration Tube is a clear tube with LEDs along the length.
The Endolumik Gastric Calibration Tube emits near-infrared light for enhanced visibility during bariatric procedures.

Endolumik’s illuminated device takes a big step for safety

March 21, 2023 | By Jim Hammerand

Endolumik’s story started a few years ago as the FDA sounded the alarm over the risks of internal surgical staplers.

In 2019, the federal agency warned healthcare providers that it had received more than 41,000 medical device reports (MDRs) related to surgical staplers and staples for internal use from 2011 to 2018. Those MDRs tallied more than 32,000 malfunctions, at least 9,000 serious injuries and 366 deaths.

Two years later, the FDA increased the risk level associated with the staplers, reclassifying the devices from Class I to Class II and subjecting them to premarket review and special controls.

Bariatric surgeon Dr. Nova Szoka had already been working on a device that could prevent some of those injuries. She envisioned an illuminated gastric calibration tube that would shine near-infrared light through stomach tissue and fat. This camera-visible fluorescence would make it easier to see the tube inside a patient, lessening the risk of a surgeon perforating the stomach or stapling the tube to the stomach during bariatric procedures.

Read more on MDO

What our editors are saying

The Endolumik gastric calibration device wasn’t just the first tubing product to win fast-tracked review under the new FDA Safer Technologies Program (STeP) — it was the first device of any kind to win authorization through the program.Managing Editor Jim Hammerand
Endolumik’s gastric calibration device is addressing a growing problem area. This was a great example of a doctor seeing a problem and coming up with an innovative solution. I think it exemplifies the importance of collaboration with surgeons in the operating room who are hands-on with the technology. They know the problems that exist and they have ideas on how to fix them.Senior Editor Danielle Kirsh
Synchron Stentrode brain-computer interface BCI system catheter delivery
The Synchron brain-computer interface system relays signals from the brain to a device in the chest, then translates the signals into action on a computer. [Image courtesy of Synchron]

Opening the brain’s secret back door: A conversation with Synchron co-founder and CEO Dr. Tom Oxley

December 11, 2023 | By Jim Hammerand

What seems like a miracle today — a paralyzed patient regaining the ability to communicate with their family without open-brain surgery — may eventually seem obvious in retrospect.

It already does to Dr. Tom Oxley, the interventional neurologist who’s CEO and co-founder of brain-computer interface (BCI) developer Synchron.

Synchron’s Stentrode device is implanted inside a blood vessel in the brain to sense neural signals and relay them to another implant in the chest. Those signals are then translated into digital commands, allowing the patient to communicate electronically or control smart devices.

The FDA has given breakthrough device designation to the system, which Synchron is testing in six patients through its COMMAND trial. It’s the first FDA investigational device exemption (IDE) for any company assessing a permanently implanted BCI.

Read more about the BCI technology

What our editors are saying

Brain-computer interface technology is one of the most promising spaces in medtech, and Synchron seems to be ahead of Elon Musk’s Neuralink, which uses open-brain surgery to place its implant versus Synchron’s catheter-placed Stentrode electrode stent. Synchron’s already been testing the safety of its device in humans, with one paralyzed patient using the thoughts-to-text system to post to social media in 2021. Since then, Neuralink’s controversial monkey trials have led to gruesome allegations of animal cruelty. This year, both companies won the FDA’s blessing to start investigational device exemption trials.Managing Editor Jim Hammerand
Delivering a stent via a catheter is tried-and-true medtech at this point, so it’s exciting to see a company like Synchron piggybacking off of that to deliver a brain-computer interface. It’ll be exciting to see what the new year brings them.Executive Editor Chris Newmarker
The technology in BCIs is incredible and will have a significant impact on giving paralyzed patients more control. There are so many companies in the BCI playing field now, and I’m looking forward to seeing where Synchron ends up.Senior Editor Danielle Kirsh
An illustration of the LimFlow System for Transcatheter Arterialization of Deep Veins, specifically the crossing stent that routes blood from the artery to the vein.
LimFlow’s crossing stent diverts blood from a diseased tibial artery to a tibial vein to deliver oxygen to a patient’s ischemic foot. [Illustration courtesy of LimFlow]

How LimFlow’s foot-saving system prevents amputations in patients with no other options

September 22, 2023 | By Jim Hammerand

LimFlow’s breakthrough system for treating chronic limb-threatening ischemia (CLTI) is the first of its kind approved by the FDA for this severe form of peripheral artery disease (PAD).

For CLTI patients who have lost blood flow below their knee and have no other suitable endovascular or surgical treatment options available, the LimFlow System for Transcatheter Arterialization of Deep Veins (TADV) is now the last resort to avoid amputation.

LimFlow’s TADV system won breakthrough device designation in October 2017 and secured FDA premarket approval (PMA) in September 2023.

Read more here

What our editors are saying

This breakthrough technology is saving feet from amputation, and one of the things that stuck with me from my conversation with Limflow CEO Dan Rose were the statistics about limb loss. Of Medicare-age patients who lose a lower limb, he said, a majority will never take another step. Limflow’s system is sparing these patients from loss that in some cases would not have previously been avoidable.Managing Editor Jim Hammerand

 

About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Tubing + Extrusion, Medical Design & Outsourcing and MassDevice. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at dkirsh@wtwhmedia.com.