GlobalData Release: Intact Vascular's PAD Endovascular Stapling Device: to Use or Not to Use?

LONDON, UK (GlobalData), 10 September 2012 - Intact Vascular, Inc., a medical device manufacturer for minimally invasive peripheral vascular procedures, recently announced the completion of a $15.5m Series A round. Series A financing is the first round of financing undergone for a new business venture after seed capital, where company ownership is often offered to external investors. Intact Vascular will use the money to conduct clinical studies and market its Tack-It-Endovascular Stapler System, a new technology for treating peripheral artery disease, which received CE mark certification earlier this year. The company’s CEO, Carol Burns, stated: “We are thrilled to have the financial backing of blue chip investors such as Quaker Partners and H.I.G. BioVentures.”

Peripheral artery disease (PAD) is a progressive condition characterized by plaque buildup and occlusion of the peripheral arteries. PAD 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 US have peripheral artery disease. Approximately 50% 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 are used to treat this debilitating condition.

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.

The Tack-It-Endovascular Stapler System is a novel endovascular stapling device designed to optimize peripheral angioplasty results. It is a 6 French (F) multi-loaded catheter that contains several self-expanding tacks. The 6.0mm length 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. Intact Vascular has begun enrolling patients into its multi-center, prospective trial to evaluate clinical performance of the Tack-It Endovascular Stapler System in superficial femoral and popliteal arteries following angioplasty.

The co-founder and chief medical officer of Intact Vascular, Peter Schneider, said in a statement: “We need to improve the results of balloon angioplasty, but right now all we can do is stent.” The plethora of 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 believes its Tack-It technology will offer a new solution to address these problems.

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, the likelihood that the Tack-It technology will be adopted by these physicians is questioned. 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 Tack-It Endovascular Stapler System has a long journey ahead before it can be marketed successfully and used in real-world practice.

PAD Endovascular Stapling Device: To Use or Not to Use?

Related Research: North America Cardiovascular Devices Market Outlook to 2018 - Cardiac Rhythm Management, Interventional Cardiology, Peripheral Vascular Devices, Electrophysiology Prosthetic Heart Valves and Others This expert insight was written by Priya Madhavan, GlobalData's analyst covering cardiovascular devices. For more information or to enquire about an interview, please contact our press office on the details below.

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