Industry News

may be delivered through standard microcatheters (no complex mixing systems or special delivery catheters are necessary).

US Patent Office grants Notice of Allowance to IceCure for its cryogenic pump

IceCure Medical has shared in a press release that it has received a Notice of Allowance from the US Patent and Trademark Office for its patent application titled ‘Cryogen Pump’. The patent will be in effect until February 2040 and was recently granted in the European Union and allowed in Japan.

The cryogenic pump enables IceCure to bring to market a new generation of cryoablation systems with a small footprint for a wide range of clinical applications. Moreover, this pump expands IceCure’s portfolio of products with a broader range of thinner cryoprobes and catheters.

IceCure’s cryogenic pump is submersible in liquid nitrogen, works in a closed circuit, enables temperature control of the cryoprobe, improves the cooling rate during a procedure, and is designed to be used for multiple procedures or longer-duration procedures without the need to refill liquid nitrogen.

Fluidx Medical unveils new embolic for neurovascular use

Fluidx Medical has released information regarding the success of the IMPASS Embolic Device in in vivo research related to middle meningeal artery (MMA) embolizations which can be used to treat chronic subdural haematomas (CSDH) on the surface of the brain.

MMA embolization is a promising option to address CSDH and is particularly appealing for elderly patients and others who cannot undergo invasive surgical procedures. Hundreds of thousands of patients with CSDHs may benefit from this minimally invasive procedure. During the procedure, a small catheter is navigated into the MMA located within the dura mater which covers the brain, then an embolic material is delivered into the vessel to block arterial flow.

The Fluidx embolic platform is expected to bring simple preparation and controllable material delivery to a range of applications. The IMPASS device is packaged in a ready-to-use syringe, can be prepped tableside by the clinician in about 30 seconds, and

Rivermark Medical announces successful firstin-human use of its FloStent System for BPH Rivermark Medical has announced the successful first-in-human (FIH) use of its FloStent System as part of the company’s RAPID-1 FIH clinical study. The procedures were performed on 15 patients by principal investigator (PI) and urologist Ingrid Perscky Arravanti (Universidad de Panamá, Panama City, Panama) and proctored by Primary Clinical Advisor and urologist Dean Elterman (University of Toronto, Toronto, Canada) at the Pacifica Salud Hospital and the Panama Clinic in Panama City, Panama. The study evaluates the delivery, safety, and clinical effectiveness of the FloStent System for treating the symptoms of benign prostatic hyperplasia (BPH).

“This therapy is extremely attractive as it offers patients instant improvement in BPH symptoms without the inconvenience and discomfort of traditional treatments,” stated Perscky Arravanti.

The FloStent System is intended to be the preferred first-line device treatment for BPH. The outpatient procedure involves the placement of a nitinol stent during a routine flexible cystoscopy with minimal patient recovery time and no need for a urethral catheter. The stent gently holds the prostatic urethra open to restore normal urinary function, preserve sexual function, and improve a patient’s overall quality of life. If desired, the device can be easily retrieved or repositioned after implantation.

IceCure releases preliminary data on ProSense cryoablation system

IceCure Medical, developer of the minimally-invasive ProSense system for cryoablation, which destroys tumours by freezing has announced interim results from the ICESECRET study for the treatment of patients with small renal masses (SRM) who cannot be offered kidney-preserving surgery. Data were presented at the Urological Association Conference (14 December, Eilat, Israel). The presentation, titled

“Renal Mass Cryoablation – Interim Analysis ICESECRET Study”, was delivered by Nasir Said (Bnai Zion Medical Center, Haifa, Israel).

According to the presentation, out of the 115 patients enrolled, 107 patients (112 lesions) returned for follow-up with a mean duration of 22.8 months and a range 12-60 months. In a subgroup of patients with no previous history of kidney cancer on the same kidney and a lesion ≤3cm, an 89.5% recurrence-free rate was observed at a mean follow-up time of 22.2 months when the procedure protocol was followed. The presentation concluded that, based on these interim results, cryoablation is safe and effective for treating renal masses under 5cm.

ICESECRET, a prospective, multicentre, single-arm clinical trial is being performed at Bnai-Zion Medical Center, Haifa, Israel, and Shamir Medical Center, Zerifin, Israel, and led by principal investigator Halahmi Sarel (Bnai Zion Medical Center, Haifa, Israel). The trial included 115 patients (138 lesions) with localised SRM of ≤5cm who were treated with ProSense cryoablation under computed tomography (CT) guidance. Full engulfment of the renal lesion, including a safety margin of 0.5cm was achieved in approximately 96% of the procedures where there was no anatomical limitation. Follow-up visits are performed at six weeks, six months, one year, and then annually up to five years after the procedure.

The company also announced its participation in the Society of Interventional Oncology (SIO) 2023 annual scientific meeting (19–23 January, Washington DC, USA).

Kenneth Tomkovich, diagnostic and interventional radiologist and director of breast imaging and interventions at CentraState Medical Center (Freehold, USA), is co-lead Investigator of IceCure’s ICE3 study for the treatment of small, low-risk, early-stage malignant breast tumours, and spoke at the meeting’s dedicated breast session.

Commenting on the growing interest in ProSense, Tomkovich stated: “We are seeing increasing interest from interventional radiologists and interventional oncologists, many of whom are practitioners who previously were not treating breast cancer patients. Their interest appears to be driven by the encouraging ICE3 interim results, which can drive the development of new patient markets for practitioners while making the minimally invasive procedure more accessible to patients.”

Penumbra launches Lightning Flash mechanical thrombectomy system

Penumbra announced the US Food and Drug Administration (FDA) clearance and launch of its Lightning Flash mechanical thrombectomy system.

“Lightning Flash features

Penumbra’s novel Lightning intelligent aspiration technology, now with dual clot detection algorithms,” the company notes in a press release, adding that the system is designed to quickly remove large blood clots in the body, including venous thrombus and pulmonary emboli (PE).

The company details that Lightning

Flash, powered by the Penumbra Engine, uses both pressure and flowbased algorithms to detect blood clot and blood flow. The catheter is made with MaxID hypotube technology, allowing an inner diameter similar to large-bore catheters while maintaining a lower profile and a soft, atraumatic tip designed to help navigate the complex and delicate anatomy of the body. When used together, the device is intended to help remove blood clots quickly while minimising potential blood loss.

Lightning Flash is part of Penumbra’s Indigo system with Lightning portfolio. The company claims that Lightning products are the only computer-aided mechanical thrombectomy systems currently available in the USA and early data have shown improvement in clinical outcomes and quality of life.

Instylla announces initial enrolment in prospective, multicentre HALT Study

Instylla has announced the enrolment of the first patient in the HALT study for the treatment of peripheral arterial bleeds. The HALT study is a prospective, multicentre, singlearm study to evaluate the safety and effectiveness of the Embrace hydrogel embolic system (HES) for the embolization of arterial bleeding in solid organs and peripheral arteries.

“Embrace HES has demonstrated rapid and durable haemostasis in preclinical studies while reducing the risk of non-target embolization. I look forward to being involved with this innovative technology which will change the standard of care for future embolizations,” commented David Tahour, chief of vascular and interventional radiology at MemorialCare Long Beach Medical Center (Long Beach, USA).

The HALT study is led by Suvranu Ganguli, section chief, interventional radiology at Boston Medical Center (Boston, USA). Patients with upper gastrointestinal bleeds, kidney, liver, or spleen bleeds, spontaneous haematomas, or other peripheral arterial bleeds such as pelvic haemorrhage may be considered suitable for this study.