Non-surgical Device for BPH Wins De Novo from FDA

FDA has granted de novo classification to a non-surgical device for the minimally invasive treatment of Benign Prostatic Hyperplasia (BPH). The iTind device was developed by Or Akiva, Israel-based Medi-Tate. However, Olympus holds the exclusive right to distribute iTind in the U.S. Here’s how iTind works. The flexible three-strut nitinol device can be placed during an in-office procedure. It expands over five days to create channels that allow urine to flow and reshape the prostate. In a release, Nacho Abia, COO of Olympus Corporation and CEO of Olympus Corporation of the Americas said, "Our investment in Medi-Tate expands our patient care offerings in BPH, adding to our market-leading plasma resection portfolio for Transurethral resection of the prostate. The agreement supports one of the company's key strategic initiatives to drive growth in our urology business and expand our minimally invasive surgical solutions. This will further enable Olympus to improve clinical outcomes, reduce overall costs and enhance the quality of life for patients." The American Urological Association said that eight out of 10 men will suffer from BPH in their lifetimes. Boston Scientific took a huge dive into the space a couple of years ago when it announced it would acquire NxThera for about $406 million. NxThera developed the Rezūm system, a technology that uses water vapor to remove excess prostate tissue thereby alleviating obstruction to flow, which ...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news

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Authors: Lin M, Bu C, He Q, Gu J, Wang H, Feng N, Jiang SW Abstract TAZ (transcriptional coactivator with PDZ‑binding motif), which is also known as WW domain‑containing transcription regulator 1 (WWTR1), a downstream effector of the Hippo pathway, has been reported to regulate cancer cell proliferation, migration and apoptosis by acting as a transcriptional coactivator. However, the function of TAZ in prostate cancer cells has not been investigated. In the present study, TAZ expression in prostate cancer (PCa) and benign prostatic hyperplasia tissues, PCa cell lines, and normal prostate epithelial cells was de...
Source: Oncology Reports - Category: Cancer & Oncology Tags: Oncol Rep Source Type: research
Urethral meatus stricture BOO stimulates bladder smooth muscle cell proliferation and pyroptosis via IL‑1β and the SGK1‑NFAT2 signaling pathway. Mol Med Rep. 2020 Apr 24;: Authors: Kai W, Lin C, Jin Y, Ping-Lin H, Xun L, Bastian A, Arnulf S, Sha-Sha X, Xu L, Shu C Abstract Bladder outlet obstruction (BOO), which is primarily caused by benign prostatic hyperplasia, is a common chronic disease. However, previous studies have most commonly investigated BOO using the acute obstruction model. In the present study, a chronic obstruction model was established to investigate the different pathological...
Source: Molecular Medicine Reports - Category: Molecular Biology Tags: Mol Med Rep Source Type: research
Abstract Identification and clinical translation of routinely tested biomarkers require a complex and multistep workflow. Here, we described a confirmatory process estimating the utility of previously identified candidate tissue miRNAs for diagnosis of prostate cancer (PCa). RNA was isolated from formalin-fixed paraffin-embedded (FFPE) prostate tissue surgically resected from 44 patients with PCa and 24 patients with benign prostate hyperplasia (BPH). Of the 92 RNA samples obtained, 68 represented 42 malignant (PCa) areas and 26 represented nonmalignant (PCa 0%) areas of the prostate tissue sections. The levels of...
Source: Biomed Res - Category: Research Authors: Tags: Biomed Res Int Source Type: research
Studies suggest that the use of alpha-blockers increases the risk of dementia in patients with benign prostate hyperplasia (BPH). Due to study limitations, the relationship between the use of alpha-blockers, such as tamsulosin, and the risk of dementia is still unclear. However, alpha1-adrenoreceptors are also present in the brain, so there is potential for adverse effects on cognitive function. Therefore, we investigated possible associations between the use of alpha-blockers and aggravation of cognitive decline in dementia patients using a clinical data analytic solution called the Smart Clinical Data Warehouse (CDW). W...
Source: Medicine - Category: Internal Medicine Tags: Research Article: Observational Study Source Type: research
This study analyzed serum-circulating miRNAs as a noninvasive biomarker in subjects with PCa and subjects with benign prostatic hyperplasia (BPH). In total, 31 PCa subjects and 31 BPH subjects were included, with the BPH group serving as the control group. RT-qPCR was used to quantify the levels of 10 miRNAs, which included miR-18a, miR-34a, miR-106b, miR-183, miR-200a, miR-301a, miR-141, miR-182, miR-200b, and miR-375 in serum. Statistical tests were used to assess the relationship between the levels of miRNAs and the clinicopathological data. A significant increase was observed in the relative expression ratios of miR-14...
Source: Journal of Immunology Research - Category: Allergy & Immunology Tags: J Immunol Res Source Type: research
This study is aimed to systematically evaluate the efficacy of tamsulosin combined with solifenacin and provide clinical evidence for treatment of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms (LUTS). PubMed, Cochrane Library, EMBASE, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, and Wanfang data information service platform were searched to select randomized controlled trials (RCTs) of tamsulosin combined with solifenacin in the treatment of BPH with LUTS. After extraction of the data, the statistical information was calculated by means of STATA 12.0. The publicati...
Source: Frontiers in Pharmacology - Category: Drugs & Pharmacology Source Type: research
Conditions:   BPH;   Enlarged Prostate (BPH);   Prostatic Hyperplasia Intervention:   Device: Prostatic Artery Embolization (HydroPearl® compressible microspheres) Sponsors:   University of North Carolina, Chapel Hill;   Terumo Medical Corporation Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
This retrospective report describes treatment of 21 patients who underwent prostatic artery embolization using 70- to 150- μm radiopaque microspheres for lower urinary tract symptoms secondary to benign prostatic hyperplasia. Seventeen patients (81%) received successful bilateral prostatic artery embolization. At a mean follow-up of 42 days (range, 25–59 days), patients showed improvement in International Prostate Sy mptom Score (n = 11; mean = 10.6; P = .001), quality of life score (n = 17; mean = 2.0; P = .02), and International Index of Erectile Function (n = 17; mean = 9.3; P = .01).
Source: Journal of Vascular and Interventional Radiology : JVIR - Category: Radiology Authors: Tags: Brief Report Source Type: research
Conditions:   BPH;   Enlarged Prostate (BPH);   Prostatic Hyperplasia Intervention:   Device: Prostatic Artery Embolization (HydroPearl® compressible microspheres) Sponsors:   University of North Carolina, Chapel Hill;   Terumo Medical Corporation Not yet recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Authors: Liu Z, Chen T, Shen M, Li K, Ma C, Ketlhoafetse A, Liu X Abstract Benign prostatic hyperplasia and its associated lower urinary tract symptoms seriously affect both the physical and mental health of older men. In order to determine the efficiency of Chinese Qigong Yi Jin Jing on prostate health in older individuals, thirty participants were randomized into either an Yi Jin Jing group (n = 15) or a control group (n = 15). After the 6-month intervention, the Yi Jin Jing group showed a significant decrease in international prostate symptom score and a significant increase in maximal urinary flow rate (compare...
Source: Journal of Aging and Physical Activity - Category: Geriatrics Tags: J Aging Phys Act Source Type: research
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