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May 30, 2019

Study Compares Different Sizes of Microspheres for Embolization to Treat BPH

May 30, 2019—Results of a single-center study comparing the safety and efficacy of prostatic artery embolization (PAE) using trisacryl gelatin microspheres of different sizes for treatment of benign prostatic hyperplasia (BPH) were published by Daniel Torres, MD, et al in Journal of Vascular and Interventional Radiology (JVIR; 2019;30:638–644). The randomized controlled clinical trial was led by Tiago Bilhim, MD, of the Department of Radiology at Hospital Saint Louis in Lisbon, Portugal.

As summarized in JVIR, the study was composed of 138 patients who underwent PAE for BPH between July 2015 and December 2016. Patients were randomized to three groups for PAE, each one using microspheres of different sizes:

  • Group A: 100–300 μm
  • Group B: 300–500 μm
  • Group C: 100–300 μm followed by 300–500 μm

All patients were evaluated before PAE and at 1, 3, 6, 12, and 18 months after PAE using mean International Prostate Symptom Score/quality of life (IPSS/QOL) and prostate volume (PV) scores.

At baseline, the groups' mean IPSS/QOL scores and PV data were comparable (P > .05):

  • Group A: 23/4.14 and 87.9 cm3
  • Group B: 23/4.09 and 89 cm3
  • Group C: 24.2/4.29 and 81 cm3

After PAE, the scores and data were:

  • Group A: 9.98/2.49 and 65.1 cm3 (P = .23)
  • Group B: 8.24/2.26 and 63.1 cm3 (P = .39)
  • Group C: 10.1/2.69 and 53.1 cm3 (P = .24)

There were 26 clinical failures. Nontarget embolization was prevented in six patients by coil embolization. Cumulative probabilities of clinical success at 18 months were (P = .68):

  • Group A: 76.7%
  • Group B: 82.6%
  • Group C: 83.3%

All adverse events were mild and self-limited, with the following rates (P < .001):

  • Group A: 86% (37 of 43)
  • Group B: 41.3% (19 of 46)
  • Group C: 58.3% (28 of 48)

Dysuria was the most frequent adverse event, occurring in 20.4% (28 of 137) of patients, reported the investigators in JVIR.

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May 30, 2019

Financing Supports Continued Development of Vesper Medical's Duo Venous Stent System

May 29, 2019

Intact Vascular Receives $25 Million Financing for Expanded Commercialization of the Tack Endovascular System