BETA
Dutch developer and manufacturer of specialty catheters for complex percutaneous coronary interventions, including guidewire support, guide extension and catheter exchange.
Interventional Medical Device Solutions (IMDS) is a privately held medical device company founded in 2008 and headquartered in Roden, Drenthe, the Netherlands. It develops and manufactures its devices in Roden. Edwin Schulting is CEO; the company lists Jason Bottiglieri as President, USA.
The portfolio includes single- and dual-lumen microcatheters, guide-extension catheters and a trapping balloon for complex PCI, chronic total occlusion and other demanding coronary procedures. Its Skeleton Backbone platform uses laser-cut metal construction in Micro Rx, ShapeIT and NHanceIT.
IMDS announced direct U.S. operations in September 2025 and states that BIOTRONIK ceased distributing its products on October 1, 2025. NHanceIT received FDA 510(k) clearance in August 2026 and a U.S. launch announcement followed in September. Current regional commercial teams and employer vacancies indicate an established commercial and manufacturing operation; revenue and financing amounts were not verified.
IMDS’s current catheter and guidewire families have matched 510(k) decisions. FDA records retain the original applicant, IMDS Operations B.V.; one decision may cover more than one branded product without becoming two authorizations. An orthopedic AXIA radial-head record belongs to a different IMDS entity and is excluded. [10][11][33][34][24][35][41]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [43][44]
Latest recorded source review: 2026-10-20.
Scope: selected product families.
Documented commercial product families.
Single-lumen catheter with a hydrophilic coating, radiopaque tip and laser-cut metal backbone for guidewire support and exchange. [20][19][10]
FDA-clearedListed in current IMDS portfolio; region and model-specific availability should be confirmed.
Combines a rapid-exchange delivery lumen with an additional over-the-wire lumen for dual-guidewire procedures. [36][15]
FDA-clearedListed in current IMDS portfolio; region and model-specific availability should be confirmed.
Low-profile rapid-exchange catheter for guidewire support and lesion access, including use with guide-extension catheters. [37][13]
FDA-clearedListed in current IMDS portfolio; region and model-specific availability should be confirmed.
Guide-extension catheter; the FG60F configuration includes distal perfusion openings. Other configurations require separate regulatory mapping. [24][14][11]
FDA-clearedListed in current IMDS portfolio; region and model-specific availability should be confirmed.
Short distal guide-extension configuration for additional support and device exchange in complex PCI. [25][14][11]
FDA-clearedListed in current IMDS portfolio; region and model-specific availability should be confirmed.
Hydrophilic guide-extension family with a coil-reinforced shaft and radiopaque distal tip. SKU-level U.S. scope requires confirmation. [40][12]
Marketed · regulatory scope variesListed in current IMDS portfolio; region and model-specific availability should be confirmed.
Company launched its single-lumen over-the-wire catheter and described the Skeleton Backbone platform. The announcement includes early physician experience, not a quantified adoption or outcomes study. [3]
FDA issued substantially equivalent decision K260559 for NHanceIT, a Class II percutaneous catheter. Clearance is distinct from launch and comparative clinical benefit. [19]
IMDS states BIOTRONIK is no longer its distributor from October 1, 2025, and directs customers to IMDS commercial teams and account setup. [39]
Company announced direct availability and appointed Jason Bottiglieri President, IMDS U.S., replacing the prior U.S. distribution model. [2]
Company LinkedIn and 2026 launch release identify 2008 as founding year. [1]
Accessed 10/20/2026