Prostate conditions and their treatment proved popular reading topics during the month of July. Interventional News reported on this subject from various angles—from an award-winning abstract on prostatic artery embolization for benign prostate hyperplasia (BPH) and the US Food and Drug Administration (FDA) 510(k) clearance of a new high-flow microcatheter, to new data to support a minimally invasive procedure to treat BPH, and a US FDA investigational device exemption for high-intensity ultrasound therapy for prostate cancer.
1) “Promising” 10-year findings on PAE for BPH presented at ET 2022
Tiago Bilhim (Saint Louis Hospital, Lisbon, Portugal) won the award of best abstract for his and co-authors’ ‘Long-term outcome of prostatic artery embolization for patients with benign prostatic hyperplasia’ at this year’s European Conference on Embolotherapy (ET; 22–25 June, Nice, France).
2) Embolx files 510(k) for new Soldier high-flow microcatheter
Embolx, a company developing microcatheters for arterial embolization procedures to treat cancerous tumours, benign prostatic hyperplasia, and uterine fibroids, has announced that the company has filed a 510(k) to the US FDA for its new line of high-flow microcatheters, Soldier.
3) First patient enrolled in Merit Medical’s WRAPSODY registry study
Merit Medical has announced the successful enrolment of the first patient in its WRAP registry study, which will evaluate the clinical benefits associated with the use of the Wrapsody cell-impermeable endoprosthesis in patients receiving haemodialysis that experience stenosis or occlusion of blood vessels required for dialysis.
4) A conversation at the cutting edge of drug-delivery nanotechnology
The University of Texas at Arlington (UTA; Arlington, USA) announced in June 2022 that Kytai Nguyen, a UTA bioengineering professor, had received National Institutes of Health (NIH) funding to develop a dual-capability biodegradable nanoparticle for use in treating peripheral arterial disease (PAD).
5) ET 2022: Choice of coil size key when embolizing in trauma cases
As part of the ‘Trauma and Emergencies’ session at this year’s European Conference on Embolotherapy (22–25 June, Nice, France), conference deputy chairman Otto van Delden (Amsterdam University Medical Centers, Amsterdam, The Netherlands) presented blunt abdominal trauma cases to delegates “to underscore the teaching points” that these types of clinical scenarios offer.
6) Ra Medical Systems receives FDA 510(k) clearance for the Dabra 2.0 catheter
Ra Medical Systems has announced receipt of US FDA 510(k) clearance for the company’s Dabra 2.0 catheter as part of the Dabra excimer laser system. The catheter features enhancements including a six-month shelf life.
Instylla, a company developing liquid embolics for peripheral vascular embolotherapy, recently announced two publications that evaluated the Embrace hydrogel embolic system (HES) in preclinical porcine haemorrhage models.
8) New data reinforce efficacy of the UroLift system for the treatment of enlarged prostate
Teleflex has announced the results of several research studies that further support the safety and efficacy of the UroLift system for men living with enlarged prostate, benign prostatic hyperplasia (BPH), or those who have a wide range of prostate sizes and/or a median lobe obstruction.
9) Northeast Scientific receives 510(k) for Turbo-Elite laser atherectomy catheter reprocessing
Northeast Scientific, a company that reprocesses single-use peripheral vascular catheters, announced recently in a press release that it has received US FDA clearance for reprocessing the Philips Spectranetics 0.9mm over-the-wire Turbo-Elite laser atherectomy catheter.
Insightec, a global healthcare company dedicated to using acoustic energy to transform patient care, announced that it has received US FDA approval for an investigational device exemption (IDE) for a clinical comparative study of the Exablate Prostate system used to treat diseased prostate tissue.
