Intact Vascular Submits IPO Filing Following FDA Approval of Tack Endovascular System for Post-Angioplasty Dissection Repair in PAD

VCBeat (WeChat Official Account: vcbeat) has learned that Intact Vascular, a private medical device company dedicated to developing minimally invasive peripheral vascular surgical solutions, recently announced that its Tack Endovascular Repair System has received FDA approval. The Tack Endovascular Repair System is a dissection repair device implanted after angioplasty in patients with peripheral artery disease (PAD).

Peripheral Artery Disease (PAD) is a common progressive circulatory disorder affecting over 200 million people worldwide. When arteries are obstructed by plaque that restricts blood flow to the legs, the body exhibits symptoms such as poor circulation, pain during walking (claudication), and changes in skin color. PAD is typically caused by atherosclerosis, which results from the accumulation of plaque within the arteries. Diabetes, smoking, hypertension, obesity, and high cholesterol are all risk factors associated with PAD. Genetic factors, family history, dietary habits, and physical inactivity also increase the risk of developing PAD. As PAD progresses to Critical Limb Ischemia (CLI), symptoms worsen significantly, manifesting as rest pain, open ulcers, and/or life-threatening conditions such as infection and gangrene. Without timely treatment, 50% of CLI patients will require amputation or face death within one year.

Percutaneous Transluminal Angioplasty (PTA) is a commonly used endovascular interventional treatment for Peripheral Artery Disease (PAD) and Critical Limb Ischemia (CLI). Stents can be deployed during the same procedure, particularly in cases of dissection. However, stenting may lead to new complications and limit options for reintervention. To prevent these complications, Drug-Coated Balloons (DCBs) have been introduced into clinical practice. Although Plain Old Balloon Angioplasty (POBA) and DCB therapy are effective, managing dissections remains a challenge, as untreated dissections can result in acute occlusion and/or thrombosis, or cause long-term adverse effects on the patient.

Tack Endovascular Repair System (Image from the official website)

The Tack Endovascular Repair System is a first-of-its-kind dissection repair device that provides precise treatment for peripheral artery dissections above or below the knee following balloon angioplasty. In a single-arm trial involving 213 patients, the safety and efficacy of the Tack Endovascular Repair System were demonstrated. The system comes pre-loaded with six self-expanding nitinol implants for above-the-knee (ATK) interventions, enabling the treatment of multiple dissections with a single catheter while leaving 70% less metal behind compared to stents. Furthermore, the Tack Endovascular Repair System minimizes vascular inflammation, promotes wound healing, and preserves future treatment options for patients with peripheral artery disease.

Intact Vascular, established in 2011, is a privately held medical device company headquartered in Wayne, Pennsylvania. Intact Vascular is dedicated to developing safe, effective, and user-friendly products for patients and physicians dealing with vascular diseases. In April 2018, the company completed a $20 million Series C financing round.

Notably, the Tack system received CE Mark certification in the European Union in January 2017. Following FDA approval, the company plans to launch a limited release of the Tack system in the United States to facilitate broader commercialization.

Bruce Shook, President and CEO of Intact Vascular, stated, “Amid a dynamic period in the PAD market, the FDA has approved Tack. With its unique combination of minimal metal and highly targeted anatomical repair, Tack has become an ideal choice for current therapies that prioritize minimizing inflammation and improving long-term outcomes. Currently, the Tack Endovascular Repair System has received approval in both Europe and the United States. We will expand its commercialization to improve the quality of life for patients with PAD.”

(Compiled by Li Chengping)