FDA OKs New Drug Delivery System from Codman Shurtleff

Codman & Shurtleff Inc., a neurological device company based in Raynham, Mass., has been granted U.S. Food and Drug Administration (FDA) approval for its Medstream Programmable Infusion System, an implantable infusion pump and catheter system used in the treatment of spasticity—a movement disorder often caused by stroke, cerebral palsy, multiple sclerosis or spinal cord injury. The device will be available through a phased roll out in the United States over the next several months.

The Medstream System is designed to deliver a continuous and accurate dose of the anti-spasm drug baclofen directly to the spinal canal to relieve severe spasticity, a condition that affects more than 12 million people worldwide. Codman claims the battery system in Medstream will last eight years, even with the high flow rates in use. Medstream also uses the Surestream Intraspinal Catheter, a purportedly kink-resistant catheter designed to deliver uninterrupted therapy.

Medstream is Codman’s fist venture into the realm of neuromodulation, technology that uses implantable devices to deliver medication or electrical impulses to treat diseases of the central nervous system.

“Neuromodulation is an important area in need of innovations that improve accuracy, reliability and device longevity,” said Stan Fisher, M.D., co-director at the Methodist Neurological Institute’s Movement Disorders and Neurorehabilitation Center in Houston, Texas, and an assistant professor of neurology at Weill Cornell Medical College in New York, N.Y. Fisher is a paid consultant of Codman & Shurtleff.

Codman & Shurtleff has received U.S. Food and Drug Administration approval for its Medstream Programmable Infusion System, an implantable pump and catheter system. Image courtesy of Codman & Shurtleff.

Medstream has a ceramic drive system that is designed to precisely control drug dosage. This system uses no gears, motors or rotating parts that could wear or stall. Medication is delivered within 10 percent of the programmed flow rate and the device is certified for use in 3-Tesla (measurement of magnetic force) MRI systems.

Use of Medstream involves the implantation of a pump about three inches in diameter and one inch thick into the patient’s abdomen. Baclofen then is transported from the pump directly to the spinal area with the Surestream Catheter. Clinicians use a computerized wireless control unit to non-invasively program dosing and flow rate for each patient based on his or her specific needs.

“The Medstream System is an important advancement that may help thousands of patients suffering from spasticity improve function,” said P. Laxmin Laxminarain, worldwide president of Codman. “We are committed to developing products that can make a meaningful difference in people’s lives and lessen the global burden of neurological disease.”

Delivery of baclofen with implantable infusion devices has been shown to reduce side effects compared to oral administration of the drug. Infusion therapy is not a cure for spasticity, but may help manage its symptoms.

Codman & Shurtleff is part of the DePuy Synthes Companies of Johnson & Johnson.

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Teleflex Gains Patent for Suture and CE Mark for Catheter Device

Teleflex’s Force Fiber sutures. Photo courtesy of Teleflex Inc.

Shortly after agreeing to sell its orthopedics business, other divisions of Teleflex continue to make gains. The company’s Semprus BioSciences subsidiary has been issued CE certification from its notified body, the DEKRA Certification Group of the Netherlands, to market the company’s Nylus peripherally inserted central catheter (PICC) with Semprus Sustain technology in the European Union.

The Nylus PICC uses a long-lasting polymer designed to reduce the attachment of platelets and blood proteins at the surface of the medical device. According to Teleflex, the device can reduce platelet adhesion and thrombus accumulation through both in-vitro and animal testing.

“This clearance enables us to further advance a new standard of care in PICC catheters,” said David L. Lucchino, co-founder of Semprus BioSciences and vice president of strategic and business development at Teleflex. “Our technology, with its ability to work in blood products and long-term duration, holds great potential to reduce infection and thrombus-related complications for patients—while substantially decreasing associated healthcare costs.”

Based in Limerick, Pa., Teleflex produces products for the critical care market. Its subsidiary, Semprus BioSciences, is headquartered in Cambridge, Mass., and was acquired by Teleflex in May.
Meanwhile, Teleflex’s maker of custom sutures and performance fibers—Teleflex Medical OEM—has received a patent from the U.S. Patent and Trademark Office for a high-strength suture. The suture combines a proprietary coreless braid design with fibers of ultra-high molecular weight polyethylene (UHMWPE), and the technology also is applicable to UHMWPE material co-braided with colored fibers to create greater visibility and contrast during surgical procedures.

“Teleflex Medical OEM continues to pursue innovations in performance fibers and specialty sutures,” said Richard Gallagher, global director of research, development and engineering for Teleflex Medical OEM.

The suture has been marketed under the name Force Fiber since 2004. Its physical properties and handling characteristics have made it a popular choice for arthroscopic repairs, the company claims. The suture is said to be flexible, nonabrasive, and silken in texture that is gentle on both biologic tissue and surgical gloves. When tied, the coreless braid is designed to flatten up in itself to provide a low knot profile that resists slippage and offers knot security.

The Force Fiber portfolio includes a range of U.S. Pharmacopeia-defined sizes, patterns such as cross and stripe, and a selection of solids and multi-colored sutures, including blue, white, green, white/blue, green/white, white/black and white/green.

Teleflex Medical OEM has private label agreements with orthopedic medical device manufacturers to market Force Fiber suture for orthopedic applications. In addition, Force Fiber suture is used as a component in numerous orthopedic medical devices.

Teleflex Medical OEM is a subsidiary of Teleflex Inc., and is headquartered in Kenosha, Wis. The performance fibers business is located in Mansfield, Mass.

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Vascular Solutions Releases Flexible Tip Microcatheter

The SuperCross FT microcatheter recently was released in the United States. Image courtesy of Vascular Solutions.

Vascular Solutions Inc. has released the SuperCross FT in the United States, a new addition to its SuperCross microcatheter line. The FT stands for “flexible tip,” and the catheter is designed to address the majority of complex interventional procedures in which a flexible tipped microcatheter is needed.
The SuperCross microcatheters consist of single lumen, over-the-wire microcatheters designed for guidewire support and exchange, as well as the infusion of contrast media or therapeutic agents in the coronary and peripheral vasculature, according to the company. The full-length braided stainless steel construction and low profile of the SuperCross microcatheters are meant to allow access to small and tortuous vessels and enhance the ability to cross plaque lesions.

“SuperCross FT is the latest offering in our line of microcatheters, and was engineered specifically in response to physician requests for a more flexible tip that provides superior deliverability over a guidewire in tortuous anatomy,” said Howard Root, CEO of Vascular Solutions.

Vascular Solutions’ original SuperCross microcatheter was launched in January 2011 with a straight tip that was designed for cases in which physicians needed extra support for the wire to advance past a challenging lesion. The next version introduced, SuperCross AT, features angled tip designs for directing guidewire placement in bifurcated lesions, and is offered in pre-set tip configurations of 45-, 90- and 120-degree angles.

“With the addition of SuperCross FT, we now have a full line of microcatheter tip designs to meet a very broad spectrum of clinical needs,” Root added. “All of our SuperCross microcatheters provide excellent deliverability and guidewire support during coronary and peripheral catheterization procedures, but we view the new FT as the new workhorse version within this product line.”

Like the other models of SuperCross, the SuperCross FT is compatible with 0.014-inch guidewires, and is available in 130 cm and 150 cm working lengths. It also has a fully embedded gold distal marker band, a clear proximal catheter hub, two depth mark indicators to help determine position within the guide catheter, and a hydrophilic coating on the distal 40 cm to enhance deliverability to the target vessel.

Based in Minneapolis, Minn., Vascular Solutions provides devices for coronary and peripheral vascular procedures.