3 New Approvals from the FDA

The FDA has announced 2 new device approvals (and one bonus end the end of the post).  All of these are pretty straight-forward in their uses so I’ll be brief this time!

1) FDA Clears First of Its Kind Suture Made Using DNA Technology

The U.S. Food and Drug Administration (FDA) today announced it has cleared for marketing in the U.S. the TephaFLEX Absorbable Suture—the first absorbable polymer suture made from material isolated from bacteria modified by recombinant DNA technology.

Recombinant DNA technology uses living organisms to create chemicals that may be more difficult to produce under standard industrial methods.

“The TephaFLEX Absorbable Suture is made from material that uses the latest DNA technology,” said Daniel Schultz, M.D., director, Center for Devices and Radiological Health, FDA. “This approach could have broader applications for medical devices that use this novel manufacturing technology.”

FDA based its decision on the company’s laboratory and animal testing that examined chemical composition, biological safety and mechanical performance of the polymeric suture. The company provided data to show that the suture could be manufactured in a consistent and safe manner.

FDA reviewed safety and effectiveness information for the device under the de novo petition process. De novo petitions were added under the Food and Drug Administration Modernization Act of 1997 to find a way for novel but less risky products to get to market. As a result of its review, FDA determined that products of this type will be regulated as class II (moderate-risk) devices.

 

2) FDA Clears Critical Limb-Saving Vascular Device

Another bonus to the truama surgeons courtesy of out friends at DARPA. 

The U.S. Food and Drug Administration (FDA) today cleared for U.S. marketing a vascular shunt, a medical device that can help save the arms and legs of soldiers critically injured in combat as well as individuals in other trauma settings and emergency situations. The Temporary Limb Salvage Shunt (TLSS), made by Vascutek Ltd. (Renfrew, Scotland), was reviewed by FDA in less than one week because of the critical need for such a device.

“This device offers surgeons a new tool to potentially avoid the need for limb amputation following traumatic injury,” said Daniel Schultz, M.D., director, Center for Devices and Radiological Health, FDA. “This device has been used successfully by other countries, and is particularly important to serve our men and women in the Armed Forces who are seriously injured in combat.”

The device works by connecting together the ends of a severed blood vessel, providing a bridge or shunt around the damaged area and restoring blood flow to the injured limb. It can be implanted on the battlefield and other remote areas to bypass damaged blood vessels and temporarily maintain blood flow to the injured limb until the patient can be transported to a surgical facility.

The TLSS is a tube formed from two layers of plastic. The device has several features that optimize its use in a trauma situation, including a self-sealing elastomer membrane that permits drugs to be injected directly into the shunt without loss of blood; beveled ends that facilitate quick and effective placement of the device within the severed blood vessel; graduated markings that provide visual confirmation of proper device placement; and extra reinforcement in the center of the device so it can be cut to a shorter length if needed.

To facilitate this accelerated review process, the device manufacturer worked in close collaboration with FDA’s Division of Cardiovascular Devices after discussion of the need for the device with the U.S. Air Force. There are currently no other devices specifically available for treating injuries of this nature.

3) the bonus- FDA Approves the First Drug for Obese Dogs

Just what we needed fat pills for fido.  This clearly show that the impetus to device and drug development is go where the money is.  A sorry comment on our priorities.  Can’t we try low-cal dog food?  Hey I got my million dollar idea!  Laparoscopic doggie gastric bypass!  I gotta go patent this one…  (check out the last line on adverse effects YUMMY!)

The Food and Drug Administration (FDA) today is announcing the approval of Slentrol (dirlotapide), a prescription drug for the management of obesity in dogs. Slentrol reduces appetite and fat absorption to produce weight loss. A veterinarian will determine whether the dog should be treated, based on the dog’s weight and general health.

“This is a welcome addition to animal therapies, because dog obesity appears to be increasing,” said Stephen Sundlof, D.V.M., Ph.D., director of FDA’s Center for Veterinary Medicine. “Veterinarians are well aware that overweight pets are at a higher risk of developing various health problems, from cardiovascular conditions to diabetes to joint problems.”

Veterinarians generally define a dog that weighs 20 percent more than its ideal weight as obese. Surveys have found that approximately 5 percent of dogs in the United States are obese, and another 20-30 percent are overweight.

Slentrol is a new chemical entity, called a selective microsomal triglyceride transfer protein inhibitor, which blocks the assembly and release of lipoproteins into the bloodstream. The mechanism for producing weight loss is not completely understood, but seems to result from reduced fat absorption and a satiety signal from lipid-filled cells lining the intestine.

The drug is given to the dog in varying amounts over the course of the treatment. The dog is given an initial dose for the first 14 days. After that, the veterinarian will assess the dog’s progress at monthly intervals, adjusting the dose depending on the dog’s weight loss. After the dog has achieved the goal weight, the drug’s manufacturer recommends continued use of the drug during a three-month period, while the veterinarian and dog owner establish the optimal level of food intake and physical activity needed to maintain the dog’s weight.

Adverse reactions associated with treatment with Slentrol include vomiting, loose stools, diarrhea, lethargy and loss of appetite.

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