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Revascularization with OrbusNeich's Genous(TM) Stent May Enable the Safe and Early Discontinuation of Dual Antiplatelet Therapy for Patients with Increased Bleeding Risk

2012-10-16 10:39 2627

British Medical Journal (BMJ) Case Report Features Patient with Immune Thrombocytopenic Purpura

HONG KONG, Oct. 16, 2012 /PRNewswire/ -- OrbusNeich today announced the publication of a case report demonstrating that revascularization with the Genous Stent may enable the safe and early discontinuation of dual antiplatelet therapy (DAPT) for challenging patients with an increased risk of bleeding, particularly during the procedure.

The case study, published in BMJ online, features a patient with chronic immune thrombocytopenic purpura (ITP) who was diagnosed with unstable angina due to a critical stenosis (90%) at the ostium of the left anterior descending (LAD) artery and a 75% stenosis of the proximal LAD artery. It was intended that the patient, who was treated with two Genous Stents, receive only one month of DAPT following the procedure. However, due to extensive bruising in the patient's forearm from antiplatelet use, the initial one month of DAPT was stopped after three days and restarted one week later when the ecchymosis was resolving. At 12-month follow-up, the patient remained asymptomatic.

"Chronic ITP is characterized by premature destruction of autoantibody-coated platelets causing persistent thrombocytopenia and increased risk of bleeding," said Charles Chan, M.D., Gleneagles Medical Center, Singapore. "Additionally, ITP patients may also have an increased risk of thrombosis versus the general population and those patients with acquired thrombocytopenia. The Genous Stent has been shown to be safe and effective in high-risk patients with ST-segment elevation acute myocardial infarction (STEAMI) and has not been associated with increased rates of late stent thrombosis when accompanied by only one month of DAPT. Thus, the Genous Stent may provide a safer option for patients, such as those with ITP, who have an increased risk of bleeding and are therefore contraindicated to long-term DAPT."

The 55-year-old male patient had a week-long history of unstable angina and was diagnosed with hypertension and hyperlipidemia as risk factors for coronary artery disease (CAD). He was diagnosed with ITP 20 years prior and did not receive long-term steroid treatment or splenectomy. The patient received DAPT and prednisone three days in advance of the procedure and was transfused with six units of platelets on the third day prior to coronary stenting.

Reference

Chan Wah Hak CM, Tan YO, Chan C. Coronary artery stenting in a patient with chronic immune thrombocytopenic purpura: a clinical conundrum. BMJ Case Rep. 2012 Sep 24.

About the Genous Technology

Genous is OrbusNeich's patented endothelial progenitor cell (EPC) capture technology that promotes the accelerated natural healing of the vessel wall after the implantation of blood-contact devices such as stents. The technology consists of an antibody surface coating that captures EPCs circulating in the blood to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis.

The Genous Stent, which has been commercially available in more than 60 countries since 2005, has been proven as a safe, effective alternative to drug eluting stents and is supported by data from more than 8,000 patients in clinical studies. There is a growing body of evidence from multiple clinical studies that the Genous Stent is effective for patients that are non-responsive to or cannot tolerate long-term DAPT.

About OrbusNeich

OrbusNeich is a global company that designs, develops, manufactures and markets innovative medical devices for the treatment of vascular diseases. Current products are the world's first pro-healing stent, the Genous Stent, as well as other stents and balloons marketed under the names of Azule™, R stent, Scoreflex™, Sapphire™, Sapphire II and Sapphire NC. Development stage products include the COMBO Dual Therapy Stent™, the only dual therapy stent to both accelerate endothelial coverage and control neo-intimal proliferation through the combination of the Genous pro-healing technology with an abluminal sirolimus drug elution delivered from a biodegradable polymer that achieves full and complete dissipation by 90 days. OrbusNeich is headquartered in Hong Kong and has operations in Shenzhen, China; Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich supplies medical devices to interventional cardiologists in more than 60 countries. For more information, visit www.OrbusNeich.com.

Follow OrbusNeich on Twitter at www.twitter.com/OrbusNeich, and learn more about the company and its innovative technology on OrbusNeich's YouTube Channel: http://www.youtube.com/user/OrbusNeichMedia.

Source: OrbusNeich
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