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International    

IMPORTANT: You are viewing the international section of Ekoscorp.com. This section may describe clearances in countries other than the United States, and therefore may contain indications and information that are outside the scope of the FDA-cleared labeling.
 
Indications

The CE Mark (CE0086) has been affixed to the EkoSonic® and MicroSonicTM products with the following indications for use:

Peripheral Vasculature

The EkoSonic Endovascular Device, consisting of the Intelligent Drug Delivery CatheterTM (IDDC) and the MicroSonic Device (MSD), is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. All therapeutic agents utilized with the EkoSonic Endovascular System should be fully prepared and used according to the instruction for use of the specific therapeutic agent.

The MicroSonic SV Endovascular Device is intended for the controlled and selective infusion of physician specified fluids, including thrombolytics, into the peripheral vasculatur
e.

Pulmonary Embolism

The EKOS EkoSonic Endovascular System is:Intended for the treatment of pulmonary embolism patients with ≥ 50% clot burden in one or both main pulmonary arteries or lobar pulmonary arteries, and evidence of right heart dysfunction based on right heart pressures (mean pulmonary artery pressure ≥ 25mmHg) or echocardiographic evaluation.

Neurovasculature

The MicroSonic SV Endovascular Device is intended for the controlled and selective infusion of physician specified fluids into the neurovasculature.

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Case Studies

Pulmonary

Treatment of Bilateral, Submassive Pulmonary Embolism with Ultrasound
Accelerated Thrombolysis, N.Kutcher, MD

Venous

Complete Lysis of Bilateral DVT in Femoral Veins, K.Weingarten, MD

Extensive DVT Resolution with Targeted USAT, T.Engelhardt, MD

Ultrasound Accelerated Thrombolysis and Rapid Clearing of DVT
in a young patient
, N.Kucher, MD

Fast relief of SVC Syndrome Symptoms with Ultrasound Accelerated Thrombolysis, K.Singh, MD

Treatment of Bi-lateral DVT with EKOS Device, D.Varnagy, MD

EKOS Ultrasound Accelerated Thrombolysis to Treat
Paget-Schrötter Syndrome
, G.Stambo, MD

Thrombolysis of the Main Portal Vein with EKOS, J.Smith, MD

Ultrasound Accelerated Thrombolysis of Chronic
Deep Vein Thrombosis (DVT)
, A.RIzzo, MD

Patency of an Acutely Thrombosed Axillary-Subclavian Vein in a
Woman with Paget-Schrötter Syndrome
, T.Kiernan, MD

MicroSonic Accelerated Thrombolysis of Long-Segment Occlusive Venous Thrombus in 6 Hours, A.Verma, MD

Arterial

Six(6) Hour EKOS Lysis of Fem-Fem and Fem-Pop Graft, K.Massis, MD

Ultrasound Accelerated Thrombolysis enables fast, very low dose clearance of large thrombus in iliac stent graft, N.Limbucci, MD

Lower Extremity Arterial Lysis After Acute on Chronic Thrombosis, J.Starr, MD

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Live Cases / Presentations

Live Cases

Acute pulmonary embolism patient demographics and case study using EKOS with procedural steps (Dr. Tod Engelhardt, East Jefferson General Hospital, Metairie, Louisiana, USA) Rapid resolution of thrombus and right ventricular dilatation following EKOS therapy (Drs. Iris Baumgartner and Nils Kucher, University Hospital, Bern, Switzerland)

 


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Presentations

Ultrasound Accelerated Thrombolysis of Massive and Sub-massive
Pulmonary Emboli

Press / Media Contact

Pauline T. Mayer
PTM Healthcare Marketing, Inc.
631.979.3780
PTM@ptmhcm.com

Press Releases

January 17, 2011: EKOS Corporation Receives CE Mark to Treat Massive and Sub-Massive Pulmonary Embolism

Media Coverage

January 2012

Study Examines Ultrasound Accelerated Thrombolysis in Acute PE

Vascular Disease Management: Dr. Tod C. Engelhardt, Discusses Catheter-Directed, 
Ultrasound-Accelerated Thrombolysis to Treat Pulmonary Embolism

Cath Lab Digest: Catheter-Directed Ultrasound Thrombolysis and the Reduction of Right Ventricular Dysfunction in Acute Pulmonary Embolism

November 2011

Diagnostic & Interventional Cardiology: Ultrasound Accelerated Thrombolysis for Acute Pulmonary Embolism Quickly Reverses Right Ventricular Dysfunction

August 2011

Endovascular Today: Low-Dose Ultrasound-Accelerated Thrombolysis Studied for Treating Acute Pulmonary Embolism

April 2011

El Paso Times: Deep vein thrombosis: Enigmatic clot condition 'can happen to anybody'

Medscape: Attacking Pulmonary Embolism -- A Practice-Changing Procedure (Medscape Log In Required To View Video)

March 2011

Vascular Disease Management: VDM Speaks with Dr. Tod C. Engelhardt About Ultrasonic-Enhanced Thrombolysis for PE

January 2011

Medical Industry Week: Ekos obtains CE mark to treat forms of PEs

Medscape: Ultrasound Plus Fibrinolysis Reduce Right Heart Dysfunction in Pulmonary-Embolism Patients

November 2010

Vascular Disease Management: Latest Study Results from VEITHsymposium™ on Ultrasound-Accelerated Catheter-Directed Thrombolysis

Radiology Daily: Ultrasound Helps Break Up Blood Clots In Lung

Endovascular Today: Study Supports the Ekos Ultrasound Device for Treating Pulmonary Embolism

Diagnostic & Interventional Cardiology: Study Shows Ultrasound Helps Drugs Dissolve Lung Clots

Medscape: Ultrasound-Accelerated Catheter-Directed Thrombolysis for Massive PE (Medscape Log In Required To View article)

Veins1.com: New Treatment Is Saving the Lives of Patients Suffering from a Pulmonary Embolism

Physicians Weekly: Ultrasound-Accelerated CDT Beneficial in PE Treatment

Cath Lab Digest: Ultrasound-Accelerated Catheter-Directed Thrombolysis in Pulmonary Embolism

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Resources

International Bibliography

Instructions for Use (IFU) / Guides by language

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