FDA approves study of implant to repair arterial wall tears

The FDA approved a clinical trial to investigate use of the Tack Endovascular System implant to repair dissections that occur in patients with peripheral artery disease who are undergoing balloon angioplasty.

In comparison to typically used stents, the Tack implant leaves behind 74% less metal, which reduces stress on the artery and preserves future treatment options, according to a company press release.

The new TOBA II trial will enroll 210 patients with advanced PAD who are undergoing balloon angioplasty in one or both legs at 30 to 40 sites in the United States and Europe. In addition, the trial will compare the Tack Endovascular System in patients undergoing standard balloon angioplasty or drug-coated balloon angioplasty.

It is estimated that dissections occur in 88% of patients undergoing angioplasty, according to the release.

Twelve-month results of the Tack Optimized Balloon Angioplasty (TOBA) trial were presented earlier this year in Germany.

“The earlier TOBA experience demonstrates that the long-term results from angioplasty can be substantially improved if we repair arterial dissections using this new approach to minimize vessel trauma while leaving as little metal behind as possible,” William A. Gray, MD, national principal investigator of the study and director of endovascular services at Columbia University Hospital, said in the release.

Reference:

Bosiers M. Tack optimized balloon angioplasty: TOBA trial 12 months results. Available at: http://www.intactvascular.com/file/manual/Bosiers_LINC_2015_TOBA_12_month_results.pdf. Accessed Oct. 7, 2015.

Disclosure: Gray is national principal investigator of the TOBA II study.