Bolt Medical, a clinical stage medical technology company, announced the successful completion of patient enrollment for its pivotal RESTORE ATK trial, marking a significant advancement in the treatment of peripheral arterial disease (PAD). The trial utilizes Bolt Medical’s innovative intravascular lithotripsy system, known as the Bolt IVL™ Above the Knee System. This technology is focused on addressing PAD with moderate to severe calcifications, a condition that complicates arterial diseases and often necessitates sophisticated therapeutic interventions.

Peripheral arterial disease (PAD) affects millions worldwide and involves the narrowing of the peripheral arteries to the legs, stomach, arms, and head—most commonly in the arteries of the legs. PAD is typically caused by atherosclerosis, a buildup of fatty plaque in the arteries that impedes normal blood flow. One of the challenges in treating PAD, particularly when severe calcification is involved, involves effectively modifying these calcifications to restore blood flow without causing harm to the patient.

The RESTORE ATK trial enrolled 95 patients at 11 centers across Europe, led by Professor Marianne Brodmann from the Medical University of Graz, Austria. This trial is particularly notable not only for its scale but also for its focus on patients with severe calcifications and chronic total occlusions (CTOs), which are complete and typically long-standing blockages in the artery.

The Bolt IVL™ system differentiates itself with a unique laser-generated energy platform that is designed to fracture both intimal and deep-seated calcium within the arterial walls. By producing acoustic pressure waves within a balloon catheter, this system can treat multiple types of calcifications including concentric, eccentric, and nodular lesions. This potentially provides a more efficient and safer alternative to existing treatment methods, which often struggle with complex calcified lesions.

The significance of this trial extends beyond the simple usage of a new medical device. According to Professor Brodmann, “Effective calcium modification remains one of the toughest challenges in treating peripheral artery disease.” She highlights the importance of the systems’ ability to treat severe cases, including those involving female patients who often represent a challenging patient cohort.

Intravascular lithotripsy (IVL) is one of the fastest-growing segments within the medical device market, driven by the increasing prevalence of cardiovascular diseases and the need for more effective treatment options. The successful completion of the RESTORE ATK trial enrollment positions Bolt Medical’s Bolt IVL™ system as a potentially transformative solution in this field.

Keegan Harper, Chief Executive Officer of Bolt Medical, emphasizes that the company is not just innovating in the realm of PAD but also focusing on the broader application of its technology across coronary and other peripheral arterial diseases. With the RESTORE ATK data set to support regulatory submissions including FDA 510k and CE Mark by late 2024, Bolt Medical is on the cusp of offering a new tool for clinicians fighting complex arterial diseases.

Currently, the Bolt IVL™ system is still in the investigational stage and awaits clearance for commercial distribution. Nevertheless, the anticipation surrounding this technology reflects the significant need for effective treatment options in tackling the global burden of cardiovascular diseases, particularly those complicated by arterial calcifications.