Product & Industry

IceCure Medical receives regulatory approval in China for commercial use of its IceSense3

Disposable Cryoprobes

IceCure Medical, developer of minimally invasive cryoablation technology, the ProSense System (marketed under the brand name IceSense3 in China), has announced the National Medical Products Administration (NMPA) of China has approved the company’s IceSense3 disposable cryoprobes for commercial use, to be used in combination with the company’s IceSense3 console.

With this latest approval, the company and its partners in China can address a significant market with its proven technology to treat malignant and benign tissue of the breast, lung, bone, liver, and kidneys.

“With approximately 430,000 new breast cancer cases in 2022 alone, and a healthcare system readily adopting new technologies that produce improved outcomes, we see China as a prime market for our cryoablation system,” stated Eyal Shamir, IceCure’s chief executive officer.

Getinge receives US FDA premarket approval for the iCast covered stent system

Getinge‘s iCast covered stent system has received premarket approval from the US Food and Drug Administration (FDA) for the treatment of patients with iliac arterial occlusive disease.

“The global market for covered stents is growing at an annual rate of 5%. Getinge will continue to ramp up capacity throughout the year in order to meet the demand,” says Elin Frostehav, president of acute care therapies at Getinge.

The iCast covered stent system, which is sold outside the USA under the brand name Advanta V12, has been used by clinicians for 20 years and is the most clinically evaluated balloon expandable polytetrafluoroethylene (ePTFE)-covered stent in the world, with clinical data published in more than 550 articles.

SurgVision’s Explorer Air II granted US FDA 510(k) clearance

SurgVision has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Explorer Air II for use with pafolacianine (Cytalux, On Target Laboratories) during intraoperative fluorescence imaging.

This is designed to achieve highsensitivity and imaging fidelity, meeting the needs of oncological intraoperative fluorescence imaging. The system allows real-time imaging during surgery and its prototype has been tested by academic centres for a variety of indications.

The Explorer Air II is also cleared in the USA and CE-marked in the EU for visual assessment of blood flow and tissue perfusion.

Currently, the identification of tumours during surgery or interventional endoscopy relies on visual inspection and palpation. Tumour tissue is sometimes difficult to distinguish from healthy tissue. As a consequence, surgical resection of the tumour is often incomplete.

Noninferiority study comparing outcomes of Focal One HIFU vs radical prostatectomy yields positive results

EDAP TMS has shared news of a presentation of positive results from a large, multicentre, noninferiority study comparing Focal One high-intensity focused ultrasound (HIFU) versus radical prostatectomy (RP) at the 38th annual congress of the European Association of Urology (10–13 March, Milan, Italy).

The study, which ran from April 2015 to September 2019, compared Focal One HIFU versus RP as a first-line treatment for patients with localised prostate cancer (grade groups <3). A total of 3,328 patients from 42 treatment centres were included: 1,967 were treated with Focal One HIFU and 1,361 underwent radical prostatectomy surgery. Patients were followed for 30 months.

Among the data that the study produced were the following points:

At 30 months, the salvage treatmentfree survival rate was higher in the HIFU arm (90.1%) compared with RP arm (86.8%);

Risk of salvage treatment was greater than 1.2-fold higher after RP (HR: 0.75, 95% CI [0.64-0.96], p = 0.02);

ICS score, a measure of urinary incontinence, was significantly lower after HIFU (0 vs 1, p < 0.001);

IIEF-5, a measure of erectile function, decreased significantly less after HIFU than after RP despite (median Δ = -4 vs -9 p < 0.001);

Postprocedural benefits of HIFU for both erectile function and urinary continence were demonstrated despite patients in the HIFU-treated group being an average of 9.6 years older (median age was 74.7 years for HIFU vs 65.1 years for RP, p>0.0001).

UK MHRA awarded £10 million to fast-track patient access to medical products

A total of £10 million has been awarded to the Medicines and Healthcare products Regulatory Agency (MHRA)—an executive agency of the UK Department of Health and Social Care (DHSC)—to help bring innovative new medicines and medical technologies to UK patients more quickly, His Majesty’s (HM) Treasury has announced.

Over the next two years, the MHRA will use the money to support development of a thorough but shortened process to speed up the approval process for cutting-edge treatments developed in the UK with the greatest opportunity to meet the country’s healthcare priorities, such as cancer vaccines and artificial intelligence (AI)-based therapeutics for mental ill-health.

It will also support the establishment of an international recognition framework, allowing the MHRA to capitalise on the expertise and decision-making of trusted regulatory partners, and provide patients with fasttrack access to best-in-class medical products that have been approved in other countries.

The first regulatory partners that the MHRA intends to build new recognition routes with are the Food and Drug Administration (FDA) in the USA and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan.

Shockwave Medical announces US launch of new peripheral IVL catheter

Shockwave Medical has announced the full US commercial availability of the Shockwave L6 peripheral intravascular lithotripsy (IVL) catheter following clearance by the US Food and Drug Administration (FDA).

A press release details that the Shockwave L6 catheter is purpose-built to modify calcification in otherwise difficult-to-treat lesions in large peripheral vessels, including the iliac and the common femoral arteries.

“The Shockwave L6 catheter pushes the boundaries of what IVL can help physicians achieve for patients with severe peripheral arterial disease,” said Frank Arko (Sanger Heart and Vascular Institute, Charlotte, USA).

“The characteristics of the new catheter allow physicians to optimise IVL therapy in large peripheral vessels, which represent over 20% of peripheral interventions performed in the USA each year. The Shockwave L6 catheter may also be beneficial when IVL is utilised to facilitate transfemoral access for large bore procedures like TAVR [transcatheter aortic valve replacement], TEVAR [thoracic endovascular aortic repair] and EVAR [endovascular aortic repair] to minimise the risks of rupture and dissection.”

According to Shockwave Medical, the L6 IVL catheter’s compact emitter configuration, in conjunction with four new device sizes (8, 9, 10 and 12mm diameters), enables effective delivery of sonic pressure waves in larger vessels.

Merit Medical expands SwiftNinja steerable microcatheter offering

Merit Medical has announced the expansion of its SwiftNinja steerable microcatheter product line. New sizes include a low-profile 2.4Fr distal diameter option in 125cm and new, longer 150cm lengths.

The 180-degree articulating microcatheter is designed to provide access to challenging peripheral and coronary vasculature without the use of a guidewire. It is part of the broader Merit Vascular portfolio that includes sheath introducers, inflation devices, embolics, and other procedural solutions.

“Unlike conventional microcatheters that are limited to a set shape, the steerable SwiftNinja is really a game-changer,” said Jason Hoffmann, interventional radiologist at New York University (New York, USA), and consultant for Merit Medical. “The tip shape and angle can be changed in real time while inside a patient, allowing for shorter procedures with less radiation exposure. Without the need for a guidewire, there is the potential for significant cost savings as well— all of which benefit the patient. The SwiftNinja has paved the way for better embolization care.”

NeoDynamics granted Chinese patent for FlexiPulse needle design

NeoDynamics, a medical device company dedicated to advancing the diagnosis and care of cancer, recently announced that the company has been granted a Chinese patent for the needle design employed in the NeoNavia FlexiPulse probe.

The front-loaded, open-tip sampling needle is designed to enable maximum tissue yield, with minimal patient trauma. The patent is an important milestone that opens up for a future commercial launch in China and strengthens the protection of the NeoNavia biopsy system. NeoNavia with FlexiPulse addresses biopsies in the axillary lymph nodes, which can be a technically and anatomically challenging site due to the proximity to blood vessels and nerves.

The Chinese patent comes on top of a similar patent granted in the USA in August 2021, followed by US Food and Drug Administration (FDA) clearance received in September 2022.

Argon Medical launches Traveler portal vein access series

Argon Medical introduces the Traveler portal vein access series as the newest addition to its portal vein access product portfolio. The product line is designed to meet the needs of physicians accessing the portal vein