Global Data Suggests Endovascular Stapler System Needs More Work

London, United Kingdom-based business intelligence provider Global Data has released research about Intact Vascular’s new technology for the treatment of peripheral artery disease (PAD).

PAD is a progressive condition characterized by plaque buildup and occlusion of the peripheral arteries. It is a critical public health issue that is associated with high mortality and morbidity and is an indicator of systemic atherosclerotic disease. According to the Centers for Disease Control and Prevention, more than 8 million people in the United States suffer from peripheral artery disease. Approximately 50 percent of patients suffering from PAD do not exhibit the symptoms of the disease, which include pain in the feet when resting and intermittent claudication. Minimally invasive procedures such as balloon angioplasty and stenting usually are used to treat this debilitating condition.

Intact Vascular Inc., a medical device manufacturer of minimally invasive peripheral vascular procedures based in Wayne, Pa., recently completed a $15.5 million Series A round of financing. Intact Vascular will use the money to conduct clinical studies and market its Tack-It-Endovascular Stapler System—a new technology for treating PAD—which received CE mark certification earlier this year.

“We are thrilled to have the financial backing of blue chip investors such as Quaker Partners and H.I.G. BioVentures,” said the company’s CEO, Carol Burns.

The money will fund the Tack Optimized Balloon Angioplasty (TOBA) study, which recently began enrolling subjects. The study will evaluate the 6 French (F) Tack-It Endovascular Stapler System for use in the superficial femoral and popliteal arteries following angioplasty. The study is a multi-center, prospective trial, and according to the company, will enroll up to 138 patients. Additionally, the funds will be used to support further development of the 4F system—used in arteries below the knee.

The 6-millimeter permanent implant consists of six pairs of anchors that juxtapose to the tissue of the artery to smooth the arterial lumen. The system is designed to incur minimal chronic injury to the vessel, allow for ‘spot’ treatment where needed and requires less foreign material in the artery.

Balloon angioplasty is the most common type of peripheral interventional procedure used to restore blood flow in the lower extremities. Despite its benefits, it can result in adverse events in patients and can lead to an irregularly shaped lumen or damage to the arterial wall by the catheter. If patients do not seek treatment, complications such as inflammation can occur, resulting in tissue loss or even amputation.

“We need to improve the results of balloon angioplasty, but right now all we can do is stent,” said Peter Schneider, co-founder and chief medical officer of Intact Vascular.

According to Global Data analyst Priya Madhavan, clinical studies that demonstrate the feasibility, safety and efficacy of drug eluting and bare metal stents have led to increased adoption and increased use in clinical practice. Although there are numerous benefits of using stents over invasive surgical procedures, there are several concerns with using this technology, including risk of restenosis and late-stent thrombosis.

Intact Vascular is hopeful its Tack-It technology will offer a new solution to address these problems.

Madhavan points out that although there are complications associated with balloon angioplasty, it has been used extensively to treat both peripheral artery and coronary artery disease. Balloon angioplasty is considered to be the gold standard of treatment among minimally invasive techniques and has a defined set of guidelines. Stents implanted into patients are deployed over the lesion using balloon angioplasty. Interventional cardiologists have used this procedure numerous times and have mastered the learning curve associated with the technique.

Given these observations, Global Data questions the likelihood of physicians adopting the Tack-It technology. The technology entails implanting a permanent catheter into the patient, increasing the risk of damage to the arterial wall and chronic inflammation that can lead to thrombosis. Long-term studies of the Tack-It technology need to be completed to validate its safety and efficacy in patients. The research suggests there is a lot more work to be done before it can be marketed successfully and used in real-world practice.