June 16, 2017
ACCESS PTS Study Demonstrates Efficacy of EKOS® Therapy for Post-Thrombotic Syndrome
Bothell, WA, 16 June 2017
BTG plc (LSE: BTG), the global specialist healthcare company, today highlights the results of the ACCESS PTS trial, presented at the Society for Vascular Medicine 28th Annual Scientific Sessions in New Orleans, June 14 to 17. The study found chronic deep vein thrombosis (DVT) patients with post-thrombotic syndrome (PTS) can be treated safely and effectively with EKOS® therapy. The ACCESS PTS protocol using EKOS® therapy is now the only treatment regimen proven to significantly reduce the signs and symptoms of PTS and show a significant improvement in quality of life.
The ACCESS PTS study is a multicenter prospective single-arm study of 73 patients with iliofemoral DVT, meeting eligibility including a Villalta Score of 8 or greater (Villalta Score measures the signs and symptoms of PTS), and who had failed three months of conservative therapy. Patients were treated with anticoagulation drugs followed by EKOS® therapy with balloon dilatation.
The study met its primary efficacy endpoint and showed a significant improvement of Villalta Scores of 34% at 30 days across 77 limbs treated among the 73 patients with a p-value of <0.0001. On average, patients treated in the study experienced a symptom reduction from severe down to borderline mild. The study also showed a 21% improvement in patients’ quality of life.1 There was one bleeding incident and one PE – meeting the study’s safety endpoint.
“ACCESS PTS demonstrates that EKOS® therapy with balloon dilatation is effective and safe in reducing the signs and symptoms of post-thrombotic syndrome for patients suffering from chronic deep vein thrombosis, while improving their quality of life,” said lead investigator Dr. Mark Garcia of Vascular & Interventional Associates of Delaware in Wilmington, Delaware. “EKOS® therapy is a useful and important option for physicians treating debilitating chronic DVT and PTS.”
In addition to Dr. Garcia, the study’s authors include Dr. Keith Sterling of Inova Alexandria Hospital; Dr. Michael Jaff of Newton-Wellesley Hospital; Dr. Kenneth Ouriel of Syntactx; Dr. Susan Kahn of Jewish General Hospital; and Dr. Anthony Comerota of Jobst Vascular Institute.
“With the ACCESS PTS study, BTG is once again demonstrating our commitment to advancing the treatment of VTE patients. Chronic DVT can be both debilitating and life threatening. Until now, most chronic DVT and PTS sufferers had no other treatment options,” said EKOS® Vice President and General Manager Matt Stupfel. “The ACCESS PTS data proves that EKOS® therapy is a safe and effective option for treating chronic DVT. EKOS® is setting the standard for interventional chronic-DVT treatment, getting patients back on their feet and on with their lives.”
About Chronic Deep Vein Thrombosis
Deep Vein Thrombosis (DVT) is a debilitating and potentially life threatening condition. It occurs when a blood clot forms in one of the deep veins in your body, limiting blood flow. It usually occurs in your leg or pelvis, but it can also occur in your arm or chest. If the clot isn’t dissolved within a few weeks, it can become a Chronic Deep Vein Thrombosis. When this happens, the blood clot interferes with blood flow and can permanently damage the valves in your veins2 creating a condition call Post-Thrombotic Syndrome (PTS). About 50% of patients with chronic DVT in the upper leg area may develop PTS which can cause disability and negatively impact the quality of life.2,3 Prior to ACCESS PTS, there was no proven treatment option for PTS.
About the EkoSonic® Endovascular System
The EKOS® system uses ultrasonic waves in combination with clot-dissolving thrombolytic drugs to effectively dissolve clots and restore healthy blood flow.
In clinical studies EKOS® therapy has been shown to speed time-to-clot dissolution, increase clot removal and enhance clinical improvement compared to either standard catheter-directed drug therapy or thrombectomy. EKOS® therapy requires significantly shorter treatment times and less thrombolytic compared to standard catheter-directed drug therapy, lowering the risk of bleeding and other complications.
1 As measured by VEINES-QOL.
2 Ashrani AA, Heit JA. J Thromb Thrombolysis. 2009;28::465-476.
3 Kahn, S et al. Arch Intern Med 2004; 164:17-26.
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BTG is a global specialist healthcare company bringing to market innovative products in specialist areas of medicine to better serve doctors and their patients. We have a portfolio of Interventional Medicine products to advance the treatment of cancer, severe emphysema, severe blood clots and varicose veins, and Specialty Pharmaceuticals that help patients overexposed to certain medications or toxins. Inspired by patient and physician needs, BTG is investing to expand its portfolio to address some of today’s most complex healthcare challenges. To learn more about BTG, please visit: btgplc.com.