OhioHealth Marion General Hospital, First in the United States to use the FLEX® Scoring Catheter to Treat Complex Dialysis Interventions

TOLEDO, Ohio, Sept. 28, 2017 /PRNewswire/ -- VentureMed Group(®), Inc. ("VMG" or the "Company"), a medical device company developing and commercializing next-generation endovascular products to treat patients with peripheral artery disease (PAD) and stenosed Arteriovenous fistulaes (AVF) and Arteriovenous grafts (AVG), today announced the treatment of the first patient in the U.S. using FLEX(®) Scoring Catheter in patients with end-stage renal disease.

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Patients who are not candidates for renal transplants or when a donor cannot be secured, become dependent on hemodialysis for the remainder of their life. This situation results in the long-term need for dialysis access. The preservation of patent, well-functioning dialysis fistulas, is one of the most difficult clinical problems in the long-term treatment of patients undergoing dialysis. As many as 25 percent of hospital admissions in the dialysis population have been attributed to vascular access complications, including fistulae malfunction, stenosis and thrombosis. Less than 15 percent of dialysis fistulas remain patent and can function without problems during the entire period of a patient's dependence on hemodialysis.

OhioHealth Marion General Hospital has announced Dr. Jose Vale was the first physician in the United States to offer VentureMed's FLEX Scoring Catheter(®) to its patients with end stage renal disease. "Vascular access is a hemodialysis patient's life line. AV fistulas and AV grafts make hemodialysis treatments possible," Dr. Vale said after successfully treating the first ever dialysis patient in the United States using the FLEX Scoring Catheter. These access sites often become occluded, making it difficult for patients, like the ones seen by Dr. Vale at Marion General Hospital, to receive these life-saving procedures. "FLEX allowed me to successfully recanalize the patient's occlusion and there have been no reports of incomplete or suboptimal dialysis treatments from the dialysis unit," Dr. Vale explained. "Innovative technologies, like FLEX, that potentially reduce overall procedure time, radiation exposure and allows for optimal results is a great option for this patient population."

According to the latest U.S. Renal Data System Annual Data Report, more than 660,000 Americans are being treated for kidney failure. Of these, 468,000 are dialysis patients. The annual Medicare spending to treat kidney failure in the U.S. is approximately $31 billion.

"Many end-stage renal disease patients receive many years or even decades of dialysis treatments," Dr. John Pigott, founder and chief science officer at VentureMed Group, said. "This leads to the creation of AVFs and or AVGs, which are prone to re-interventions. The use of percutaneous interventions such as thrombectomy, thrombolysis and/or angioplasty have become universally included in dialysis treatment algorithms. A vessel-prep device, like the FLEX Scoring Catheter, with its Dynamic Scoring(®) Technology could potentially prolong the time between re-interventions. We are proud to partner with pioneers like Dr. Vale, from Marion General Hospital, to treat many more patients who are suffering from this disease."

About Dr. Jose Vale, Vascular Surgery, Marion General Hospital:

José Vale, MD, FACS is an endovascular specialist who has been practicing at Marion General Hospital since 1992. His practice includes general surgery, robotics, oncological and vascular surgery.

About OhioHealth:

OhioHealth is a nationally recognized, not-for-profit, charitable, healthcare organization with Methodist roots. Based in Columbus, Ohio, OhioHealth is currently recognized as one of the top five large health systems in America by Truven Health Analytics, an honor it has received six times.

Serving its communities since 1891, it is a family of 28,000 associates, physicians and volunteers, and a network of 11 hospitals, 50+ ambulatory sites, hospice, home-health, medical equipment and other health services spanning a 40-county area.

OhioHealth hospitals include OhioHealth Riverside Methodist Hospital, OhioHealth Grant Medical Center, OhioHealth Doctors Hospital, OhioHealth Grady Memorial Hospital, OhioHealth Dublin Methodist Hospital, OhioHealth Hardin Memorial Hospital, OhioHealth Marion General Hospital, OhioHealth O'Bleness Hospital, OhioHealth Mansfield Hospital, OhioHealth Shelby Hospital and OhioHealth Rehabilitation Hospital.

For more information, please visit our website at www.ohiohealth.com.

About FLEX Scoring Catheters:

FLEX utilizes its Dynamic Scoring Technology in the femoral-popliteal arteries or within native or synthetic Arteriovenous fistulae or grafts. Its unique design allows the operator to easily prepare a diseased vessel in a single insertion without the need for multiple balloon inflations or device exchanges. The FLEX Scoring Catheter is intended for use with percutaneous transluminal angioplasty (PTA) catheters to facilitate dilation of stenosis in the femoral and popliteal arteries and treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

About VentureMed Group:

VentureMed Group, Inc. is a commercial-stage medical device company that develops and markets cost-effective interventional devices to improve the treatment of peripheral artery disease. The Company's innovative product platforms are designed to improve clinical outcomes and reduce procedural costs.

VMG's lead platform is the FLEX Scoring Catheter. FLEX has the ability to treat the complete range of peripheral vessel diameters and lesion lengths and has been described as a safe, efficient and intuitive tool for the treatment of PAD by interventionalists. FLEX is FDA approved and has CE Mark approval and is available for sale and distribution in the United States and Europe.

VentureMed is located in Toledo, Ohio, USA. For more information, please visit the company's website at www.venturemedgroup.com.

Venture Med Group®, FLEX(®) and FLEX Scoring Catheter® are registered trademarks of VentureMed Group. FLEX AV Catheter(TM) is trademarked by VentureMed Group.

Contacts:

VentureMed Group Media:
Bradley Ford
Marketing
Email: bford@venturemedgroup.com

VentureMed Group Investor Relations:
Gary Smith
Chief Executive Officer
Email: gsmith@venturemedgroup.com

OhioHealth Marion General Investor Relations:
Jill Fazekas
Communications & Media Relations Manager
OhioHealth Marion General Hospital & Morrow Co. Hospital
Office: 740.383.8838
Email: Jill.Fazekas@ohiohealth.com

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SOURCE VentureMed Group, Inc.