People are confused and critical over the role of the Office of Combination Products at the FDA, which determines the regulatory pathway for products that combine drug, device or biologics.

Combination products are complex says venture capitalist Mike Carusi, with ATV Ventures, at a time when simplicity is what the healthcare system is demanding.

Still, these three combination product categories are worth knowing because of the potential benefits down the road.

Bioresorbable Drug Eluting Stents or Scaffolds

These may revolutionize the field of interventional cardiology. Drug-eluting stents were a huge leap in the field of coronary artery disease but because they leave behind the stent, there is a potential for complications such as late stent thrombosis.

Bioresorbable scaffolds and stents on the other hand are temporary leaving no foreign bodies behind after the vessel has healed. These therefore may reduce the adverse events such as stent thrombosis and reduce complications from bleeding.

There are several companies in this field. 480 Biomedical, a spin off from Arsenal Medical, has created Stanza, a self-expanding bioresorbable vascular scaffold for superficial femoral artery disease.

Abbott Vascular is testing the Absorb bioresorbable vascular scaffold that is absorbed in the body in two years. The product has launched abroad.

Steroid Injecting Implants 

There are various applications of implants delivering steroids that are considered more effective than taking injections periodically.

One company using the technology in an ENT application is Intersect ENT. It has developed the Propel implant, an absorbable device that delivers the appropriate drug directly into the sinus for chronic sinus patients undergoing sinus surgery.

Another implant delivering steroids is directed at diabetics who suffer macular edema or swelling in the eye that causes blurred vision. It's known as the Ozurdex steroid implant and is being tested by the Lahey Clinic.  

Drug-Coated Balloons  

Drug-Coated balloons have the same clinical goal as drug-coated stents - prevent restenosis in patients whose arteries have become blocked. 

Several companies are in this space including players like Medtronic that recently completed enrollment for its IN.PACT drug eluting balloon. Then there is CV Ingenuity, a startup that has an investigational device as well.

And the promise of a similar technology developed at Lutonix led to its acquisition by C.R. Bard in 2011.

Lutonix's vice president of quality, George Papandreou, will be discussing the safety and efficacy issues surrounding the design of such products at a session devoted to combination products in Boston, April 10 at a conference organized by the publisher of MDDI.

-- By Arundhati Parmar, Senior Editor, MDDI

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