Teleflex is using CIRSE 2026 to highlight new clinical experience with the Dynetic-35 Balloon-Expandable Cobalt Chromium Stent System, including a completed feasibility study suggesting that iliac artery disease can be treated successfully through an artery in the wrist rather than the traditional femoral route in the groin. The investigator-initiated BIONETIC-TRA study enrolled 25 patients and reported 100% procedural success using transradial access, defined as successful delivery and deployment of the Dynetic-35 across the target lesion with residual stenosis no greater than 30%. The study also reported a low rate of asymptomatic radial artery occlusion and what Teleflex characterized as a non-complex learning curve.
The evidence is early and primarily procedural. BIONETIC-TRA had only 30 days of follow-up and was conducted at a single German center, so it does not establish that radial iliac intervention produces better long-term outcomes than femoral access. Nevertheless, the result addresses an important device-engineering problem: the iliac arteries are far from the wrist, meaning a stent system needs enough usable catheter length, pushability and radial strength to reach and treat a substantial peripheral lesion through a relatively small radial access sheath. Teleflex says Dynetic-35 supports 6F compatibility and usable lengths of up to 170 cm.
Why do doctors normally access the iliac arteries through the groin?
The common femoral artery has traditionally provided a direct and relatively short route into the aortoiliac circulation. A physician can puncture the artery in the groin, advance wires and catheters upward into the iliac vessels and deploy angioplasty balloons or stents across stenotic lesions.
That route is efficient, but it is not ideal in every patient. The femoral artery itself may contain heavy calcification, stenosis, previous surgical changes or scar tissue, particularly in people with diffuse peripheral artery disease. Bleeding, pseudoaneurysm and other access-site complications can also occur after femoral puncture.
Patients with advanced age or critical limb ischemia can have exactly the anatomy that makes groin access more difficult. Teleflex says BIONETIC-TRA was designed partly around these challenges, testing whether a radial route could offer an alternative when common femoral access is complicated or undesirable.
Radial access is already deeply established in coronary intervention, where evidence has supported reduced access-site bleeding and earlier ambulation in many settings. Extending the technique to iliac arteries is mechanically harder because of the much greater distance from wrist to target.
What did BIONETIC-TRA actually test in the 25 patients?
The study was an investigator-initiated observational feasibility study conducted at the Vascular Center of Klinikum Hochsauerland in Arnsberg, Germany. ClinicalTrials.gov records actual enrollment of 25 patients, with study activity beginning in July 2022 and completion in June 2025.
The primary assessments included transradial technical success, access-site complications, stroke, death and conversion from radial to femoral access. Technical success required successful delivery of the Dynetic-35 stent to the lesion and treatment leaving no more than 30% residual stenosis.
Teleflex reported 100% procedural success when the data were presented at LINC 2026. The company also described asymptomatic radial artery occlusion as occurring at a low rate but did not disclose the exact event count in its September CIRSE announcement. That omission matters because a 25-patient study can make percentages unstable, and readers should not infer that no access complications occurred.
The trial’s principal conclusion is therefore feasibility: operators were able to reach and treat all intended iliac lesions using the wrist approach without converting those cases into a procedural failure.
Why is reaching an iliac artery from the wrist technically difficult?
The distance is the first challenge. A catheter introduced through the radial artery must travel through the arm, across the central arterial circulation and down into the abdominal aorta before reaching the iliac vessels.
Standard peripheral devices may not have enough working length for that path. Longer systems can also become harder to push accurately, particularly when vascular anatomy is tortuous or calcified.
The radial artery itself is smaller than the femoral artery, limiting sheath size and therefore the profile of devices that can be introduced. Dynetic-35’s 6F compatibility is intended to make the system suitable for relatively small radial access while still delivering a balloon-expandable iliac stent.
Balloon-expandable stents also need substantial radial strength because iliac lesions can be calcified and mechanically demanding. Teleflex describes Dynetic-35 as being manufactured from cobalt-chromium L-605 alloy and incorporating its proBIO silicon-carbide coating.
The device is therefore not merely a standard iliac stent placed on a longer catheter. Its dimensions and delivery architecture are important to making radial access practical.
What is peripheral artery disease and why are iliac lesions important?
Peripheral artery disease occurs when atherosclerosis narrows arteries supplying the limbs. Iliac artery disease affects major vessels in the pelvis and can reduce blood flow throughout the lower extremities.
Symptoms can include exertional leg pain, reduced walking distance and, in advanced disease, rest pain or chronic limb-threatening ischemia. Treatment depends on severity and can range from medical therapy and exercise to endovascular intervention or surgery.
Balloon angioplasty and stenting can restore vessel diameter without open bypass surgery. The access route does not change the fundamental purpose of treatment: the lesion still needs to be crossed, expanded and supported with a device that maintains blood flow.
What radial access changes is the pathway used to reach the lesion.
Could wrist access improve patient comfort and recovery?
Experience from coronary procedures suggests radial access can allow earlier ambulation because patients do not need prolonged pressure or bed rest to protect a femoral puncture. Teleflex highlights patient comfort, earlier mobility and potentially shorter hospitalization among theoretical advantages of radial vascular access.
Those advantages should not be assumed automatically for iliac intervention. Peripheral procedures may be longer and use different anticoagulation, equipment and patient populations than ordinary coronary angiography.
BIONETIC-TRA also did not randomize 25 radial procedures against 25 femoral procedures. It therefore cannot establish differences in hospital stay, bleeding, pain or cost.
A larger comparative study would be needed to determine whether a technically successful wrist procedure actually translates into better recovery.
What is radial artery occlusion and why does it matter?
The radial artery can thrombose or become occluded after catheterization. Many patients remain asymptomatic because the hand also receives blood through the ulnar artery, but losing radial patency can eliminate a future access route and can matter in patients who may need the artery for other procedures.
Teleflex reported a low rate of asymptomatic radial artery occlusion in BIONETIC-TRA but did not provide the exact number in the September release.
Device profile, sheath size, anticoagulation and compression technique can influence this complication. Longer or more complex peripheral procedures might theoretically expose the radial artery to more instrumentation than brief coronary diagnostics.
That is one reason safety data from 25 patients should be viewed as encouraging rather than definitive.
What do we know from the larger BIONETIC-I study?
Dynetic-35 has also been evaluated in the separate BIONETIC-I study, which enrolled 160 patients across multiple European centers to assess treatment of peripheral iliac lesions. That study was not specifically a transradial feasibility trial; its purpose was broader assessment of the stent’s safety and effectiveness, with follow-up planned through several years.
The availability of a larger stent-specific clinical program matters because BIONETIC-TRA answers only whether the device can be delivered effectively through the radial route. Long-term vessel patency, reintervention and stent performance require a larger dataset.
Teleflex cites longer-term BIONETIC-I experience in supporting the product at European congresses, while the radial study adds a new access strategy to the established device program.
Is Dynetic-35 approved for sale in the United States?
No. Teleflex explicitly states that the Dynetic-35 Peripheral Balloon-Expandable Stent System is not approved for sale in the United States and that availability and indications differ by country.
That distinction matters because Teleflex is a U.S.-listed medical-device company and is presenting the system at an international radiology congress, which can easily create the impression of global commercial availability.
BIONETIC-TRA is European clinical experience. It does not represent an FDA trial or authorization.
Any eventual U.S. development strategy would need to meet FDA requirements applicable to the intended indication and device configuration.
Could radial iliac stenting become routine rather than a niche alternative?
The strongest case may initially be in patients for whom femoral access is undesirable rather than in replacing the groin route for every intervention.
An elderly patient with heavily calcified common femoral arteries, prior surgery or severe bilateral lower-extremity disease may benefit disproportionately from an alternative access route. In such patients, the option of entering through the wrist can expand the operator’s procedural choices.
For routine adoption, physicians would want evidence of comparable technical success across many centers, low radial complication rates and no penalty in procedure time, radiation exposure or contrast use.
Operators also need equipment that covers a broad enough range of lesion lengths and vessel diameters without introducing excessive complexity.
BIONETIC-TRA shows that 25 procedures could be completed successfully at an experienced center. The next question is reproducibility.
What should interventional specialists watch next?
A larger multicenter study specifically comparing transradial and transfemoral iliac intervention would provide the most useful evidence. It could evaluate bleeding, radial occlusion, procedure time, patient comfort, time to ambulation, length of stay and conversion rates in addition to lesion success.
Longer follow-up is also needed to establish that the access route does not compromise stent placement or long-term patency.
The current result nonetheless gives Teleflex a strong proof-of-feasibility number: 25 patients, 100% reported procedural success and no need to frame radial iliac stenting as merely theoretical.
The key limitation is equally clear. Twenty-five carefully selected procedures with 30-day follow-up cannot establish superiority over femoral access.
Dynetic-35 is consequently best viewed as a device enabling another procedural option. If larger studies preserve the technical success while showing fewer access problems or faster recovery, wrist access could become considerably more important in peripheral intervention.