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Innovations and Trials in Medical Technology

Recent advancements in medical technology include the launch of the CrossWise RF transseptal access system by Circa Scientific, completion of enrollment in a pivotal trial for Inquis Medical's Aventus thrombectomy system, a distribution agreement between Medtronic and Contego Medical, a $12 million Series A round for Relief Cardiovascular, CE mark approval for Johnson & Johnson MedTech's dual-energy catheter, a temporary pause on Varipulse PFA system cases by Johnson & Johnson MedTech, and the completion of a first-in-human study by AerWave for its lung denervation therapy.

Circa Scientific has launched its CrossWise RF transseptal access system, designed for precise puncturing of the heart's septal wall using radiofrequency energy. Inquis Medical completed enrollment in a pivotal trial for its Aventus thrombectomy system, aimed at evaluating the safety and efficacy of the device for treating thrombus. Medtronic entered into an exclusive U.S. distribution agreement with Contego Medical, becoming the sole distributor for Contego's portfolio of products. Relief Cardiovascular secured $12 million in Series A funding to initiate a first-in-human feasibility study for its Relief System, a smart transcatheter implant. Johnson & Johnson MedTech received CE mark approval for its dual-energy ThermoCool SmartTouch SF catheter, featuring irrigated, contact-force sensing capabilities. However, Johnson & Johnson MedTech has temporarily paused all U.S. cases using its Varipulse pulsed field ablation (PFA) system due to stroke reports. AerWave completed a first-in-human feasibility study of its disease-modifying ultrasound lung denervation therapy, aimed at treating chronic obstructive pulmonary disease, and raised $12 million to advance this therapy.
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Inquis Medical Completes Enrollment in Pivotal Trial of Aventus Thrombectomy System for Pulmonary Embolism

Inquis Medical has completed enrollment in its AVENTUS Clinical Trial, a pivotal IDE trial for the Aventus Thrombectomy System, designed to treat pulmonary embolism (PE).
The trial enrolled 130 patients with intermediate-risk PE across more than 20 clinical sites in the United States.

Axcynsis Therapeutics' AT03-65 Receives FDA IND Clearance for CLDN6-Targeting ADC

Axcynsis Therapeutics received FDA clearance for its IND application for AT03-65, a differentiated CLDN6-targeting antibody-drug conjugate (ADC).
AT03-65 leverages Axcynsis' AxcynDOT™ technology for precise drug delivery to tumors expressing CLDN6, a target in various cancers.

Heart Device Impresses FDA; Stryker Acquires Inari Medical

Alleviant Medical's new atrial shunt for heart failure treatment receives FDA breakthrough device designation. Stryker's acquisition of Inari Medical highlights the complementary nature of their vascular portfolios. Additionally, advancements in TAVR procedures and the EU availability of the Harmony TPVR system mark significant milestones in cardiovascular care.

Johnson & Johnson MedTech Temporarily Pauses U.S. Varipulse Cases

Johnson & Johnson MedTech has announced a temporary pause on all U.S. cases using its Varipulse pulsed field ablation (PFA) system starting January 5, as it investigates the root cause of four reported issues.

RapidPulse's Cyclic Aspiration System Receives FDA Approval for Ischemic Stroke IDE Study

RapidPulse has received FDA approval to begin an Investigational Device Exemption (IDE) study for its cyclic aspiration system in acute ischemic stroke (AIS).
The IDE study will enroll patients in the U.S. and Europe in 2025 to evaluate the safety and efficacy of RapidPulse's pulsed aspiration method.

TRiCares Announces First U.S. Implantations of Topaz TTVR System in Early Feasibility Study

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Inquis Raises $40M for Pivotal Trial of Clot Removal Device

Inquis Medical has secured $40 million in funding to complete a pivotal trial for its Aventus thrombectomy system, aiming for a 2025 product launch. The Aventus system, which received 510(k) clearance in November 2023, offers a non-surgical method for removing blood clots, utilizing aspiration technology similar to Inari Medical’s Flowtriever but with added sensing technology for enhanced precision.

Shockwave Medical's Javelin IVL Catheter Demonstrates Promising Results in PAD Treatment

Shockwave Medical's Javelin IVL catheter met its primary endpoints in treating peripheral artery disease (PAD), showing a major adverse event rate of just 1.1%.
The Javelin catheter achieved a 99% technical acute procedural success rate, offering a potential alternative for difficult-to-cross lesions in PAD patients.

Conformal Medical Initiates GLACE Study for Next-Gen LAAO Device with ICE Imaging

Conformal Medical has begun its GLACE study to assess the use of intracardiac echocardiography (ICE) imaging during left atrial appendage occlusion (LAAO) procedures using the CLAAS AcuForm device.
The GLACE study aims to enroll approximately 80 patients across multiple European sites to validate the use of ICE with the innovative LAAO technology in patients with non-valvular AFib.

Johnson & Johnson MedTech Receives CE Mark Approval for Advanced Dual Energy THERMOCOOL SMARTTOUCH SF Catheter

Johnson & Johnson MedTech has achieved European CE mark approval for its Dual Energy THERMOCOOL SMARTTOUCH SF Catheter, a breakthrough in treating cardiac arrhythmias by integrating radiofrequency and pulsed field energy. This innovation allows for seamless energy mode switching during procedures, improving treatment flexibility and effectiveness for paroxysmal atrial fibrillation.

Reference News

[1]
Medical Tubing and Extrusion
medicaltubingandextrusion.com · Mar 12, 2019

Circa Scientific launched the CrossWise RF transseptal access system, FDA-cleared for precise septal wall puncture. Inqu...

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