A Medical Device Daily

Angiotech Pharmaceuticals (Vancouver, British Columbia), a pharmaceutical and medical device company, reported results from its European first-in-man study for its Vascular Wrap paclitaxel-eluting product, saying the trial “produced evidence” that the Vascular Wrap reduced the overall incidence of leg amputation and prolonged limb retention time for patients in the treatment arm relative to the control group.

It said that for the patients that underwent an amputation during the study period, the mean interval to amputation for patients treated with the Vascular Wrap was 156 days — more than double the mean interval to amputation for the control, which was 76 days.

William Hunter, MD, president/CEO of Angiotech, said, “We believe this is an important step forward in improving the quality of life of patients suffering from end-stage peripheral arterial disease. It appears from this trial that being treated with our Vascular Wrap provides patients with an option to better manage their disease, and a much greater chance of retaining their leg for a longer period of time following synthetic bypass grafting.”

He said that the Vascular Wrap is intended to prolong the effectiveness of vascular surgery, “so to demonstrate a greater than 100% improvement in the duration of limb retention seems to bode well for other potential uses, like for hemodialysis graft patients.”

The Vascular Wrap component is a biodegradable mesh implant incorporating Angiotech’s paclitaxel technology in a novel biomaterial with the goal of mitigating scar formation caused by abnormal blood flow thereby potentially enhancing graft patency rates in AV-access patients as well as in peripheral bypass procedures.

The objectives of the two-year study were to assess safety and clinical performance of the in combination with an ePTFE vascular graft following surgery to treat patients suffering from advanced peripheral arterial disease in their lower limbs. The Vascular Wrap in combination with an ePTFE graft was compared to a control group of patients that received standard of care — an ePTFE graft alone.

Key findings:

  • Adverse events (AE) leading to death occurred in a lower percentage of treated subjects (11%, 8/71), than in controls (18%, 7/38).
  • The incidences of adverse events and serious adverse events were comparable in treated (graft with Vascular Wrap) and control (graft alone) groups.
  • No adverse events were considered by the investigators to be related to the use of the Vascular Wrap.
  • Overall, the action taken to resolve AEs was similar for the two groups, and the outcomes were comparable.
  • When comparing the treatment arm relative to the control, the Vascular Wrap maintained the mean diameter of the distal anastomosis during the 24-month trial compared to a decrease in mean diameter in the control arm. This reached statistical significance (p=0.0333).
  • The trial produced evidence that the Vascular Wrap reduced the overall incidence of amputation and prolonged limb retention time. The control group had an almost 19% higher probability of losing their limb compared to the treatment arm.
  • The treated group had an overall lower incidence of amputations (15.5%, 11/71 subjects) compared to the control group (18.4%, 7/38).
  • While the sample size was small, diabetic subjects appeared to experience benefits from the Vascular Wrap.

The single-blind study enrolled a total of 109 patients at nine clinical centers in Europe as well as the Dutch Antilles and randomized patients with peripheral vascular disease in a 2:1 fashion. The treatment arm enrolled patients with a synthetic bypass graft plus the Vascular Wrap paclitaxel-eluting mesh, and the control arm enrolled patients with a synthetic bypass graft alone.

Peripheral vascular disease progresses in the lower extremities to critical limb ischemia (CLI), characterized by leg pain at rest, skin ulceration, gangrene, and ultimately amputation. Among patients diagnosed with CLI, 25% may require amputation within a year.

Limb salvage depends on restoring and maintaining blood flow in the CLI patient. Surgical interventions include endovascular therapy (angioplasty and stenting). However, in patients with severe occlusion and stenosis, small vessel occlusion, calcified lesions, as well as those with diabetes, surgical bypass provides a final option to manage the occlusion(s) prior to amputation.

The success of grafting to restore blood flow depends on inflow and outflow of the graft. The trial results announced today shows trends that suggest that the use of the Vascular Wrap in these procedures may increase the success rates of vascular graft surgery.

Angiotech’s Vascular Wrap paclitaxel-eluting mesh/ePTFE graft combination product technology is designed and in development for use in hemodialysis access and peripheral arterial bypass surgery. It consists of both the ePTFE graft and the Vascular Wrap paclitaxel-eluting mesh.

PCA3 gene-based test wins CE mark

A new test to detect prostate cancer based on DiagnoCure ’s (Quebec City, Quebec) PCA3 gene has received CE-marking, the company said.

“I believe this is a significant moment for our company and for all those concerned with prostate cancer,” said John Schafer, president/CEO of DiagnoCure. “We are confident that clinicians and patients will share our excitement at the potential of this important new prostate cancer diagnostic tool.”

In 2003, the company granted an exclusive worldwide license for the use of the PCA3 technology in prostate cancer diagnosis to Gen-Probe (San Diego).

Gen-Probe said that its PCA3 test, which measures the expression of the prostate cancer-specific gene, PCA3, will be formally launched later this month at the meeting of the British Association of Urologic Surgeons (BAUS) in Birmingham, England.

Gen-Probe reports conducting studies at seven European institutions to validate the test. It said four molecular pathology laboratories across Europe are in the process of setting up the assay for the reporting of clinical results.

At a European symposium in October, Dr. Jack Schalken’s keynote presentation discussed data suggesting the importance of PCA3 in predicting the outcome of a prostate biopsy. Being able to predict whether a second biopsy is needed could potentially spare many patients the uncomfortable experience of a second procedure.

Dr. Frans Debruyne, emeritus professor of urology at UMCN called PCA3 the most important discovery in his over 20-years as head of the department.