Devon Medical Products Receives FDA 510(k) Clearance for CircuFlow Sequential Compression Pump Models

KING OF PRUSSIA, Pa.--()--Devon Medical Products, a manufacturer and distributor of creative, safe, and cost-effective medical devices, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its CircuFlow 5100 and 5200 Sequential Pump models that treat venous insufficiency and lymphedema. Devon Medical Products will feature the CircuFlow and other medical devices at the Health Care Association of New Jersey’s (HCANJ) 62nd Annual State Health Care Convention & EXPO at the Trump Taj Mahal Casino Hotel in Atlantic City from October 26-28.

Lymphedema occurs when the lymph system is damaged or blocked. Lymphatic fluid builds up in soft body tissues and causes swelling most commonly in the arm or leg, and occasionally in other parts of the body. Primary lymphedema can develop when lymphatic vessels are missing or impaired.

Secondary lymphedema can be caused by cancer and cancer treatment surgeries that damage lymph vessels or require the removal of lymph nodes, such as with breast, prostate or testicular, head and neck, bladder or colon cancers. According to the Lymphedema Awareness Foundation (LAF), 15% to 20% of breast cancer related lymphedema in the U.S. has been determined by the American Cancer Society (ACS).

“Lymphedema is a common, incurable condition that, left untreated, can result in serious infections,” says Dr. John A. Bennett, CEO of Devon Medical Products. “Daily pneumatic, sequential compression using devices like the CircuFlow has proven to help treat lymphedema and venous insufficiency by stimulating the correct flow of fluid. The CircuFlow is the latest medical device in our product line, and we are proud to offer patients another quality device that can improve their quality of living.”

CircuFlow applies gradient pressure to mimic the lymphatic system by moving lymphatic fluid in the correct physiological direction. Patients wear four-chambered sleeves that surround the infected area. The CircuFlow pumps and releases air into and out of the sleeves’ chambers to stimulate circulation and keep fluid from building up.

Devon Medical Products has a staff of FDA-regulatory experts based in the United States and other international offices. The company works with various worldwide distributors such as ReMarx Medical Services, a distributor of pneumatic compression devices.

“ReMarx is committed to supporting the treatment of chronic edemas including lymphedema, venous insufficiency, and other vascular disorders, and Devon Medical Products shares this goal,” says Gerry Makoid, president of ReMarx Medical Services. “Devon Medical Products is an expert in medical device engineering and distribution, and we are proud to offer the CircuFlow product and help patients control and ease their symptoms.”

The CircuFlow’s automatic deflation feature is a market-first. The device uses a vacuum to deflate the sleeves in two to five minutes after therapy is administered. The 5100 and 5200 models have different aesthetic and user features, including digital and mechanical controls, chamber-based gradient pressure adjustments, and screen displays.

Visit Devon Medical Products in booth #438 at the HCANJ convention for more information.

About Devon Medical Products

Devon Medical Products (www.devonmedicalproducts.com) is a Devon International Group company that provides the medical community with creative, safe, and cost-effective medical products. The company has cultivated an exclusive line of innovative medical devices designed to advance healthcare treatments and maximize safety for healthcare workers and patients worldwide. The company is headquartered in King of Prussia, Pennsylvania, and has international offices staffed with bilingual engineers, product developers, and FDA-regulatory experts.

Contacts

Devon Medical Products
Darren M. Behuniak
Director, Marketing & Communications
610.755.4958
dbehuniak@devonhealth.com

Release Summary

King of Prussia, PA-based Devon Medical Products announces U.S. Food and Drug Administration (FDA) 510(k) clearance to market its CircuFlow 5100 and 5200 Sequential Pump models to treat lymphedema.

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Contacts

Devon Medical Products
Darren M. Behuniak
Director, Marketing & Communications
610.755.4958
dbehuniak@devonhealth.com