Medical Device Network

Prospective study finds polymer plug effective in treating pelvic pain

The study, carried out by the Clínica Universidad de Navarra, found that the polymer plug could allow patients to return to their daily lives with only a single pelvic implant.

A prospective study examining the use of a single polymer plug in treating pelvic venous disease (PVD) has found Shape Memory Medical’s IMPEDE-FX embolisation plug could represent an advancement over traditional methods, leaving no trace behind in a patient.

The study, published in the European Journal of Vascular and Endovascular Surgery, examined the US-based Shape Memory Medical’s IMPEDE embolisation plug, finding that the device has the potential advantage of leaving nothing behind in terms of permanent implants, without jeopardising the efficacy of treatment.

Chronic pelvic pain can be caused by PVD and is traditionally treated using permanent alloy or metal implants, but concerns remain given the prevalence of chronic pelvic pain among younger female patients prompting clinicians to seek out alternatives.

Carried out by researchers at Clínica Universidad de Navarra in Madrid, Spain, researchers found that all five patients examined in the study returned to their daily activities the day after their procedures and showed a decrease in their pain scores at the 30-day follow-up. Additionally, none of the patients experienced signs or symptoms of post-embolisation syndrome.

Study researcher Dr Jose Ignacio Leal Lorenzo said: “This novel approach, using a single shape memory polymer plug, has the potential advantage to reduce the metal left behind without impacting efficacy.”

Shape Memory Medical says that its IMPEDE embolisation plug contains proprietary shape memory polymer technology, which is a low-density, porous embolic material that is crimped for catheter delivery and self-expands upon contact with blood.

Additionally, the PVD study stated that there is potential benefit in terms of device-related costs to be explored due to patients potentially not needing multiple implants to treat the same condition.

Ted Ruppel, president and CEO of Shape Memory Medical, said: “We understand there are challenges diagnosing patients with PVD, as they come through various referral pathways. We appreciate the work that was done in Madrid with collaboration from both the vascular surgery and interventional radiology unit along with the department of gynaecology and obstetrics to publish this first-of-its-kind prospective study.”

In August 2022, Shape Memory Medical launched a trial, dubbed the AAA-SHAPE early feasibility trial, examining the IMPEDE-FX RapidFill Device. The company also received a CE mark for its TrelliX Embolic Coil System, which helps to obstruct blood flow in case of vascular abnormalities.