Medical Tubing and Extrusion

Medical tubing and extrusion technologies

The 10 most-read catheter-based innovation stories of 2023

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pictures of catheter-based devices and innovations on a white background.
Clockwise from top left: Abbott’s TactiFlex, Surmodic’s SurVeil, Biosense Webster’s QDOT and Medtronic’s PulseSelect. [Images courtesy of the companies]
This year was a year of firsts for catheter-based innovations, most notably for renal denervation and pulsed field ablation.

ReCor Medical won an FDA panel nod for its renal denervation system in August. The panel voted in favor of the safety and efficacy of its Paradise ultrasound renal denervation (RDN) system for treating hypertension. The same FDA advisory panel decided not to recommend Medtronic’s Symplicity Spyral RDN. Both devices are catheter-delivered and treat the nerves leading to the kidneys, but Medtronic’s device uses radiofrequency energy instead of ultrasound. In November, ReCor became the first company to win FDA approval for RDN, with Medtronic following about a week later.

Medtronic was the first company to win FDA approval for pulsed field ablation (PFA) to treat atrial fibrillation in December. The path to that approval was much anticipated by Medical Tubing + Extrusion‘s readers this year – innovation news related to Medtronic’s PulseSelect PFA system comprised two of the top 10 most-read articles on MT+E.

Looking back at this year’s catheter coverage at Medical Tubing + Extrusion, we analyzed the most popular catheter innovations of 2023 based on reader interest. The top articles on MT+E were from a combination of major medtech manufacturers like Medtronic and J&J, and smaller private developers like Field Medical and Alleviant Medical. Catheter news that dominated our readers’ interest was largely cardiology-based, showing a growing interest in treating heart failure and atrial fibrillation. For comparison, our 2022 most-read catheter-based coverage covered a broader range of innovations like eustachian tube dilation balloons and stroke treatment.

Here are the top 10 catheter-based innovations that dominated the news on Medical Tubing + Extrusion in 2023.

An image from an Alleviant Medical animation that shows the Alleviant System using a short pulse of energy for controlled creation of anAlleviant System using a short pulse of energy [Image courtesy of Alleviant Medical]
Medtronic PulseSelect Pulsed-Field Ablation technologyThe PulseSelect for pulsed-field ablation. [Image courtesy of Medtronic]
Field Medical FieldForce Catheter Tip (1)The FieldForce catheter tip. [Image courtesy of Field Medical]
Johnson & Johnson Biosense Webster Optrell mapping catheter with Trueref Carto 3The Optrell mapping cathter. [Image courtesy of Biosense Webster]
Urotronic Optilume BPH Catheter System drug-coated balloonThe Optilume BPH catheter system drug-coated balloon. [Image courtesy of Urotronic]
This Abbott marketing illustration shows its TactiFlex Ablation Catheter, Sensor Enabled for treating AFib.The TactiFlex Ablation Catheter, Sensor Enabled [Image courtesy of Abbott]
Biosense Webster QDot Micro CatheterThe QDOT Micro catheter. [Image courtesy of Biosense Webster]
This Surmodics marketing image shows three SurVeil drug-coated balloons for treating PAD.SurVeil drug-coated balloons [Image courtesy of Surmodics]

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1. Alleviant Medical raises $75M for no-implant heart failure treatment

Alleviant Medical announced in February it raised $75 million to support a global pivotal trial of its catheter-delivered interatrial shunt to treat heart failure.

The Alleviant System is a transcatheter device that uses a short energy pulse to create a durable passage between the heart’s left and right atrium to reduce excess pressure within the left atrium. Alleviant Medical officials describe it as a less-invasive approach.

Read more about the funding raise and the company’s ALLAY-HF study >>

2. Medtronic pulsed field ablation system wins CE mark

Medtronic said that in November, it received a CE mark for its PulseSelect pulsed field ablation system.

PulseSelect uses a non-thermal approach to preferentially target the pulmonary veins for ablation, avoiding unwanted injury to surrounding structures, which is a risk of current ablation technologies. It uses a proprietary biphasic waveform, a unique built-in over-the-wire design and a 20-degree forward tilt. Medtronic EVP Sean Salmon discussed the technology with us shortly before winning FDA approval.

Read more about the CE mark and PulseSelect >>

3. Farapulse founder’s Field Medical raises $14M for next-gen cardiac ablation tech

In September, Field Medical closed an oversubscribed seed round with investments reaching $14 million.

The company earmarked the funds to support preclinical-to-clinical development activities. That includes first-in-human studies slated to begin in early 2024.

The company’s core products — the FieldForce Catheter and FieldForce Generator — use proprietary FieldBending technology. According to a news release, this addresses the limitations of first-generation PFA technologies and unmet needs in cardiac care. It treats any cardiac arrhythmia while expanding its capabilities to treat complex ventricular arrhythmias.

Read more about Field Medical’s tech. >>

4. J&J’s Biosense Webster launches AFib mapping catheter

Johnson & Johnson’s Biosense Webster announced in July it launched the Optrell mapping catheter with TrueRef technology.

The company designed Optrell as a high-density diagnostic catheter powered by its Carto 3 system. It has small electrodes arranged in a fixed array formation to provide high-definition electrophysiological mapping of complex cardiac arrhythmia cases.

Optrell with TrueRef maps cases like persistent AFib, redo AFib ablation, atrial tachycardia and ventricular tachycardia.

Read more about Optrell. >>

5. FDA approves drug-coated balloon for BPH symptoms from Urotronic

Urotronic announced that the FDA approved its Optilume BPH catheter system for alleviating urinary symptoms caused by benign prostatic hyperplasia.

The company designed Optilume as a minimally invasive surgical therapy that combines mechanical dilation using a proprietary double-lobe balloon with concurrent localized delivery of paclitaxel. This treats lower urinary tract symptoms secondary to BPH.

Urotronic previously received FDA approval for Optilume to treat male urethral strictures. In these cases, the balloon inhibits new scar tissue growth that can occur after endoscopic dilations. Mechanical dilation with Optilume BPH achieves an anterior commissurotomy. The delivery of paclitaxel aims to maintain luminal patency during healing.

Read more about the DCB from Urotronic. >>

6. Abbott scores regulatory wins in electrophysiology

In February, Abbott announced two new regulatory approvals related to its TactiFlex and FlexAbility ablation catheters.

The TactiFlex ablation catheter, sensor-enabled (SE) received a CE mark for treating abnormal heart rhythms such as atrial fibrillation. The company’s FlexAbility ablation catheter, SE, also received an expanded indication from the FDA for treating patients with complex heart conditions.

TactiFlex has a unique flexible tip and contact force sensing. Its tip design has a laser-cut pattern that flexes when in contact with the heart wall to direct irrigation flow to the treated tissue and to increase catheter stability by up to two times for consistent therapy delivery.

Read more about TactiFlex. >> 

7. Data supports Biosense Webster RF ablation for treating AFib

JACC: Clinical Electrophysiology published data in May from the Q-FFICIENCY study evaluating Biosense Webster’s QDOT Micro catheter’s safety and 12-month effectiveness.

The QDOT Micro catheter, a next-generation radiofrequency (RF) ablation catheter, uses advanced, high-energy ablation. It offers improved temperature monitoring, optimized irrigation and higher signal resolution. Standard QMODE delivers RF ablation using up to 50 watts for up to 60 seconds, while QMODE+ enables ablation at 90 watts for up to four seconds. The QDOT Micro catheter received a CE mark in 2020 and FDA approval in 2022.

Biosense Webster designed the catheter to provide temperature control through intelligent adjustment of power and/or irrigation fluid output based on real-time temperature management. This temperature control safely enables the use of higher average RF power.

Read more about the study results and QDOT Micro catheter. >>

8. FDA approves Surmodics SurVeil drug-coated balloon

Surmodics announced in June that the FDA granted approval for its SurVeil drug-coated balloon (DCB) for percutaneous transluminal angioplasty.

SurVeil treats peripheral artery disease (PAD) with a proprietary drug-excipient formulation for a durable balloon coating. The company says it manufactures the system using an innovative process that improves coating uniformity.

Read more about SurVeil here. >>

9. FDA clears Pounce LP thrombectomy system from Surmodics

Surmodics received FDA 510(k) clearance for its Pounce low-profile (LP) thrombectomy system in June.

The company designed Pounce for the nonsurgical removal of thrombi and emboli from the peripheral arterial vasculature. It performs this removal in vessels between 3.5 mm and 6 mm in diameter.

Pounce LP, a new addition to the platform, treats vessels between 2 mm and 4 mm in diameter. These sizes represent vessels typically found below the knee. The Pounce system features three components: a 5 Fr delivery catheter, a basket wire and a funnel catheter.

Learn more about Pounce. >>

10. Medtronic reports positive study results for PulseSelect pulsed field ablation system

In May, Medtronic reported positive findings from a secondary analysis of the PULSED AF study for its pulsed field ablation technology.

The analysis showed positive results for the PulseSelect system, including atrial arrhythmia (AA) burden reduction.

Medtronic designed PulseSelect to treat atrial fibrillation with a new ablation modality that uses pulsed electric fields to isolate the pulmonary veins, according to the company. The non-thermal approach targets the pulmonary veins to avoid unwanted injury to surrounding structures.

Read more study results. >>

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.