IMDS Launches NHanceIT Microcatheter in the U.S. for Complex Coronary Interventions
Interventional Medical Device Solutions (IMDS), a specialty catheter company developing purpose-built technologies for complex percutaneous coronary intervention (PCI), chronic total occlusion (CTO), and complex high-risk indicated procedures (CHIP), has announced the U.S. commercial launch of NHanceIT™, an over-the-wire, single-lumen microcatheter designed to support physicians when treating challenging coronary lesions.
The launch expands IMDS’s portfolio of specialized catheter technologies and introduces its proprietary Skeleton Backbone™ construction platform to a broader group of U.S. interventional cardiologists. According to the company, NHanceIT was developed specifically to address difficulties associated with lesion crossing, particularly in complex coronary anatomy where resistance, tortuosity and calcification can make guidewire and catheter advancement more challenging.
Complex PCI procedures often require physicians to navigate highly resistant or anatomically difficult lesions while maintaining precise control of interventional equipment. As coronary interventions have become increasingly sophisticated, operators are treating patients with more complex disease, including heavily calcified lesions, chronic total occlusions, tortuous vessels and previously stented segments. IMDS believes that catheter construction needs to evolve alongside these procedural demands.
The company says NHanceIT represents a new approach to catheter construction intended to provide physicians with greater control, pushability and torque transmission during demanding coronary interventions.
Addressing Challenges in Complex PCI
Complex PCI can present significant technical challenges for interventional cardiologists. As lesion resistance increases, advancing a guidewire or delivering a catheter to the target area can become difficult. In heavily calcified or tortuous coronary anatomy, physicians may need to generate substantial forward force while simultaneously maintaining precise rotational control.
Catheter design plays an important role in these procedures. IMDS notes that conventional catheter construction has historically relied on braided or coiled designs, an approach that has remained broadly consistent for decades.
The company’s Skeleton Backbone technology is designed as an alternative to traditional catheter construction. Rather than relying primarily on braided or coiled structures, the technology incorporates a solid, laser-cut stainless-steel tube that can be tailored across different sections of the catheter.
This construction approach is intended to allow specific portions of a catheter to be engineered according to the clinical challenge being addressed. IMDS says the technology can provide different mechanical characteristics along the length of the device, potentially supporting the combination of pushability, torque response, flexibility and structural integrity required during complex coronary procedures.
NHanceIT is the latest product in the IMDS portfolio to use the Skeleton Backbone platform, following the company’s Micro Rx™ and ShapeIT™ catheters.
Designed for Lesion Crossing
NHanceIT is an over-the-wire, single-lumen microcatheter designed to facilitate lesion crossing in challenging coronary anatomy.
During complex PCI, the ability to advance a microcatheter through a difficult lesion can be critical to procedural progress. When a lesion is highly resistant, heavily calcified or located within tortuous anatomy, operators may require a device capable of transmitting force efficiently from the proximal end of the catheter toward the distal tip.
IMDS says NHanceIT’s Skeleton Backbone construction is designed to maintain force transmission from the catheter hub to its distal end. The company also highlights the device’s 1:1 torque response, which is intended to provide controlled rotational movement during navigation.
The catheter’s reinforced metal construction is designed to support controlled entry into resistant lesions. An integrated radiopaque tip is intended to provide visibility under fluoroscopy while maintaining structural integrity during navigation through calcified anatomy and previously stented segments.
Together, these features are intended to give physicians a catheter that can be used in demanding coronary interventions while maintaining familiar procedural handling.
Early U.S. Commercial Experience
The U.S. launch follows early commercial experience with NHanceIT, including one of the first U.S. commercial cases involving the device.
Jaikirshan Khatri, MD, Director of Cardiac Catheterization Laboratories at NewYork-Presbyterian/Weill Cornell Medical Center, described the catheter’s performance favorably following an early commercial case. He highlighted the importance of pushability and torque control when navigating tortuous and calcified anatomy and noted NHanceIT’s ability to reach and cross challenging lesions.
Such early physician feedback is important for specialty catheter technologies because complex PCI procedures can involve highly variable anatomy and require operators to adapt their device selection to specific lesion characteristics.
IMDS intends to continue building real-world experience with NHanceIT following its U.S. launch, with a particular focus on physicians who regularly perform complex PCI, CTO and CHIP procedures.
Physician Input in Device Development
Emmanouil Brilakis, MD, PhD, Director of the Center for Complex Coronary Interventions at Allina Health Minneapolis Heart Institute and co-developer of NHanceIT, also provided clinical input during the development of the catheter.
According to Brilakis, the development process focused on addressing practical requirements encountered by interventional cardiologists during complex PCI. He emphasized the importance of creating a catheter that feels familiar during routine use but can provide additional support when anatomy becomes more demanding.
This combination of familiarity and enhanced mechanical support is central to IMDS’s positioning of NHanceIT. Rather than requiring physicians to adopt an entirely different procedural workflow, the company says the catheter is intended to fit naturally into complex PCI procedures while offering additional capabilities when lesion resistance increases.
Clinical input from experienced complex coronary operators can help medical device developers identify the specific mechanical characteristics that matter during real-world procedures. These can include the ability to transmit force, rotate predictably, maintain structural integrity and navigate challenging anatomy without compromising procedural control.
Expanding the Skeleton Backbone Platform
For IMDS, the U.S. launch of NHanceIT represents more than the introduction of a single catheter. It also expands the company’s broader Skeleton Backbone technology platform.
Edwin Schulting, CEO of IMDS, said the launch represents an important step in making the company’s proprietary catheter technology available to more physicians in the United States and internationally.
The company believes that the Skeleton Backbone platform can enable catheter designs to be tailored to specific clinical applications. By modifying the structure across different catheter sections, IMDS aims to create devices optimized for particular procedural challenges rather than relying on a standardized construction approach across multiple applications.
This strategy could be particularly relevant in complex coronary interventions, where the mechanical requirements of a device can differ significantly depending on the anatomy and procedure.
For example, an operator treating a chronic total occlusion may require different catheter characteristics from those needed to navigate a tortuous vessel or cross a resistant calcified lesion. IMDS’s platform approach is intended to support the development of specialized devices addressing these distinct requirements.
Supporting Complex and High-Risk Coronary Procedures
The growing complexity of coronary interventions has increased the importance of specialized tools for interventional cardiologists. Complex PCI may involve patients with advanced coronary artery disease, extensive calcification, chronic total occlusions, difficult vessel anatomy or prior interventions.
CHIP procedures can be particularly demanding because patients may have significant comorbidities and complex coronary anatomy, requiring careful planning and specialized equipment.
CTO interventions present another area in which catheter performance can be particularly important. Crossing a complete coronary occlusion may require multiple devices and techniques, and operators often need precise control when navigating through challenging anatomy.
By focusing on purpose-built catheter solutions for complex PCI, CHIP and CTO procedures, IMDS is positioning its product portfolio toward specialized segments of interventional cardiology where device performance can have a significant effect on procedural workflow.
NHanceIT’s ability to transmit force and torque through its metal-based Skeleton Backbone construction is intended to address some of the mechanical challenges encountered in these procedures.
U.S. Availability and Future Expansion
With the U.S. commercial launch of NHanceIT, IMDS is expanding access to its Skeleton Backbone technology in one of the world’s largest markets for interventional cardiology.
The technology is currently represented in the United States by Micro Rx, ShapeIT and NHanceIT, giving physicians access to multiple catheter configurations developed around the same underlying construction platform.
Following the launch, IMDS plans to continue expanding NHanceIT availability while working with CTO and CHIP operators to generate additional real-world experience. This approach will allow the company to gather feedback from physicians using the device across different lesion types and procedural scenarios.
As complex coronary interventions continue to evolve, catheter technologies designed around specific procedural challenges may become increasingly important. Devices that combine pushability, torque control, flexibility and structural integrity can help operators navigate difficult anatomy while maintaining procedural precision.
The launch of NHanceIT therefore marks a significant development in IMDS’s strategy to provide specialized catheter solutions for challenging coronary procedures. By applying its Skeleton Backbone technology to a microcatheter designed for lesion crossing, the company is seeking to address a longstanding need in complex PCI: maintaining reliable control and device performance when conventional catheter construction may be insufficient.
IMDS’s continued expansion of the Skeleton Backbone platform also signals its broader ambition to develop a family of purpose-built interventional devices rather than relying on a one-size-fits-all approach. As the company expands NHanceIT availability and works with experienced CTO and CHIP operators, real-world clinical use will provide additional insight into how the technology performs across the diverse challenges encountered in complex coronary intervention.
About IMDS
Founded in 2008 in Roden, the Netherlands, Interventional Medical Device Solutions (IMDS) develops and manufactures advanced solutions designed to address the evolving complexity of PCI. The company focuses on expanding procedural capabilities within familiar workflows and delivering precise, repeatable performance when it matters most.