MR angiography-planned prostatic artery embolization for benign prostatic hyperplasia: single-center retrospective study in 56 patients.

PURPOSE: We aimed to evaluate the advantages of magnetic resonance angiography (MRA)-planned prostatic artery embolization (PAE) for benign prostatic hyperplasia (BPH). METHODS: In this retrospective study, MRAs of 56 patients (mean age, 67.23±7.73 years; age range, 47-82 years) who underwent PAE between 2017 and 2018 were evaluated. For inclusion, full information about procedure time and radiation values must have been available. To identify prostatic artery (PA) origin, three-dimensional MRA reconstruction with maximum intensity projection was conducted in every patient. In total, 33 patients completed clinical and imaging follow-up and were included in clinical evaluation. RESULTS: There were 131 PAs with a second PA in 19 pelvic sides. PA origin was correctly identified via MRA in 108 of 131 PAs (82.44%). In patients in which MRA allowed a PA analysis, a significant reduction of the fluoroscopy time (-27.0%, p = 0.028) and of the dose area product (-38.0%, p = 0.003) was detected versus those with no PA analysis prior to PAE. Intervention time was reduced by 13.2%, (p = 0.25). Mean fluoroscopy time was 30.1 min, mean dose area product 27,749 µGy•m2, and mean entrance dose 1553 mGy. Technical success was achieved in all 56 patients (100.0%); all patients were embolized on both pelvic sides. The evaluated data documented a significant reduction in IPSS (p < 0.001; mean 9.67 points). CONCLUSION: MRA prior to PAE allowed the identification of PA in 82.44% of the cases. MRA-planned PAE is an effective treatment for patients with BPH.

Median approval times for class III medical devices have been well above statutory deadlines set for FDA and CMS.

The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) play key roles in making safe and effective medical devices available to the public. Since 1997 Congress has passed "modernization" laws that specify statutory deadlines for these agencies to review manufacturers' applications for premarket approval--the process by which the FDA evaluates the safety and effectiveness of class III medical devices, those that pose the highest risk--and applications for national coverage by Medicare. We questioned whether these reforms shortened approval time at the FDA and CMS. We searched publicly available databases for information for the period from January 1, 1995, through December 31, 2008, and calculated median time to approval. After initially declining, the FDA median approval time increased after 2002 and nearly reached the 1997 prereform levels by the end of the study period. In contrast, the CMS median approval time decreased steadily over the period. Neither agency consistently met the statutory deadline of 180 days for approval of premarket applications or national coverage. Congress should consider the underlying causes for these delays in the development of future modernization legislation.