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BD (Becton, Dickinson and Company), a leading global medical technology company, announced it has completed the acquisition of TVA Medical, Inc., a company that develops minimally invasive vascular access solutions for patients with chronic kidney disease requiring hemodialysis.
In the U.S. alone, there are more than 440,000 patients with End-Stage Renal Disease (ESRD) who are surviving on hemodialysis. The addition of TVA Medical enables BD to offer the everlinQ™ endoAVF System, a new endovascular arteriovenous (AV) fistula creation technology that adds to the company’s ESRD portfolio of dialysis catheters, drug coated balloons, standard angioplasty balloons and endovascular stent graft products. This technology will further improve BD’s ability to serve physicians and their patients by providing a minimally invasive option for creating critical AV fistulas (joining arteries to veins to create a circuit) for hemodialysis procedures.
“The addition of TVA Medical allows BD to provide another innovative device to physicians who treat patients suffering from chronic kidney disease requiring hemodialysis,” said Steve Williamson, worldwide president of Peripheral Intervention at BD. “This technology is highly complementary to our Peripheral Intervention offerings, and we will continue to bring new technologies to market that improve our category-leading ESRD portfolio. This is a great example of our continued strategy to use tuck-in acquisitions to advance category leadership.”
Hemodialysis, a form of treatment for kidney failure patients, is a procedure that removes wastes, salts, and fluid from a patient’s blood when the kidneys can no longer perform these functions. Vascular access is considered a “lifeline” for hemodialysis patients. Options for vascular access include central venous catheters, AV grafts and surgical AV fistulas. Surgical fistulas are currently the preferred vascular access option for hemodialysis patients, resulting in lower mortality rates, fewer infections and lower cost of dialysis delivery compared to central venous catheters.
On June 22, the U.S. Food and Drug Administration (FDA) announced De Novo marketing authorization for the everlinQ endoAVF System. The system uses two, thin, flexible, magnetic catheters that are inserted into the ulnar artery and the ulnar vein in the arm through a small puncture. When placed close to each other, the magnets in each catheter attract, pulling the vessels together. After confirming alignment, an electrode from the venous catheter delivers radiofrequency energy to create the connection between the artery and vein. Embolization of the brachial vein is then recommended. The fistula is confirmed with an angiogram (X-ray image of the vascular system) to show that arterial blood is flowing to the low-pressure venous system. The procedure minimizes the amount of vessel and skin trauma compared to traditional fistula creation using open surgery. The everlinQ endoAVF System enables an additional AV fistula location for patients than what is typically done surgically. The device is already commercially available in Europe and Canada.
“The FDA’s authorization and joining BD are the culmination of many years of hard work by a dedicated team of innovators at TVA Medical, and I’d like to thank them for their tireless efforts to get us to these important milestones,” said Adam L. Berman, co-founder of TVA Medical. “BD will enable us to deliver to physicians and patients what we believe is a highly desirable and transformative endovascular technology as an integral part of a broader ESRD-focused portfolio of solutions. I look forward to the next chapter of our history as part of the BD family.”
This transaction is not expected to have a material impact on BD results for fiscal 2018 or 2019. Future results for TVA Medical will be reported under the Peripheral Intervention business within the Interventional Segment at BD. The company used cash on hand to finance the transaction. This transaction does not impact the company’s previously communicated commitment to deleverage as part of the Bard acquisition. Terms of the transaction were not disclosed.
For Further Information
More on the vascular access device market in the U.S. can be found in a series of reports published by iData Research, entitled the U.S. Market Report Suite for Vascular Access Devices and Accessories 2018. The U.S. market for vascular access devices and accessories includes implantable ports, port needles, central venous catheters (CVCs), peripherally inserted central catheters (PICCs), peripheral intravenous catheters (PIVCs), midlines, dialysis catheters, ultrasound systems, tip guidance devices, catheter securement devices, syringes, and needles.
The iData report series on vascular access devices covers the U.S., Brazil, South Korea, Japan, Australia, China, India, and 15 countries in Europe including Germany, France, the United Kingdom (U.K.), Italy, Spain, Benelux (Belgium, Netherlands, and Luxembourg), Scandinavia (Finland, Denmark, Sweden, and Norway), Portugal, Austria, and Switzerland. Reports provide a comprehensive analysis including units sold, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about vascular access device market data, register online or email us at [email protected] for the U.S. Market Report Suite for Vascular Access Devices and Accessories 2018 brochure and synopsis.