Blog 5/6 – FDA Approved Devices Ft. Stents & Catheters

In 2023 FDA gave the green light to several minimally invasive medical devices. Last year the global market size of stents accounted for more than USD 8.6 billion and now the trajectory is expected to rise by 4% between 2022- 2028. Catheterization is a type of co-procedure that is projected to reach $49.5 billion (approx) by 2031. While Cardiac Catheters were on the list in 2022 as well, Prostatic Catheters made an entry to the list in 2023.

Stent delivery systems have been used in a range of different medical procedures for many years. Innovation in this area of medical device design hasn’t stopped even after years of usage and new highly innovative solutions continue to develop including the capability of delivering stents to the body’s most difficult-to-reach locations like the brain, prostate etc. New innovations are also improving the performance of stent delivery systems in existing applications. The objective of a stent delivery system design process is to develop a device that delivers optimal levels of performance while enhancing the confidence of medical professionals.


Optilume BPH Catheter System by Urotronic is a unique minimally invasive surgical therapy (MIST) that combines mechanical dilation using a proprietary double-lobe balloon with concurrent localized delivery of paclitaxel for the treatment of lower urinary tract symptoms (LUTS) secondary to BPH. The Optilume BPH Catheter System is used to treat obstructive urinary symptoms associated with BPH in men who are age 50 and older.

iCast Covered Stent System by Atrium Medical Co. is intended to treat narrowed blood vessels that supply blood to the pelvis and legs (iliac arteries). The stent is used in people who have narrowed iliac arteries caused by atherosclerosis, the collection of fatty substances such as cholesterol that form “plaque” along the lining of the arteries.

Bolton Medical RelayPro Thoracic Stent-Graft System is designed to repair damage of the largest artery in the body (aorta) in the area behind the heart. Doctors use the RelayPro Thoracic Stent-Graft System for endovascular repair of blood vessel damage, or lesions, of the descending thoracic aorta. 

Endologix, DETOUR System is intended to treat narrowed or blocked arteries that carry blood to the knee and lower leg (superficial femoral and popliteal arteries). The DETOUR System is used in people who have narrowing or a blockage in the superficial femoral and popliteal arteries and who are not good candidates for surgical repair. 

FDA approves MicroPort CRM’s next-generation implantable pacemakers. The VEGA Steroid-Eluting Endocardial Pacing Lead is an insulated wire with a screw-in tip that is connected to a permanently implanted pulse generator, or pacemaker device, to carry signals from the heart muscle to the pulse generator and electrical impulses back to the heart to keep the heart beating in a normal rhythm (pace). 


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By |2023-08-31T14:35:54+00:00August 31st, 2023|News|Comments Off on Blog 5/6 – FDA Approved Devices Ft. Stents & Catheters

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