Cayenne Medical Inc. has received FDA clearance for the iFix(TM) Interference Screw System for use in bone-tendon-bone ACL reconstruction procedures. These are the first FDA approved screws to hit the market that are made from polyetheretherketone (PEEK) plastic, which is radiolucent and highly biocompatible and has superior biomechanical strength. PEEK is a completely bio-inert material and, hence, screws made from this material do not result in foreign body reactions in patients.

Biomedical engineering researchers at the Queensland University of Technology (QUT) are working on developing a computer modeling program that would allow surgeons to simulate scoliosis surgery. This would enable surgeons to determine the most effective procedure before entering the operation theater. Professor Clayton Adam, a member of QUT’s Institute of Health and Biomedical Innovation (IHBI), said, “Spine surgery is one of the most complicated and painstaking operations because surgeons cannot afford to damage the delicate spinal cord.”

Baxter Healthcare Corp., which produces about 50% of the heparin drug sold in the U.S., has halted the production of the drug’s multi-dose injectable form, following reports of serious allergic reactions in several patients. The death of four patients may also be linked to the drug.

The FDA said that most of the reactions, such as breathing difficulty, excessive sweating, nausea and falling blood pressure, had been in patients receiving a high dose. Heparin is a blood thinner used to prevent blood clots in patients undergoing kidney dialysis and heart surgery.

It is expected that the current robotics market, which hit $626.5 million in 2007, will reach an incredible $1 billion by 2008, and is estimated to rise to $14 billion by 2014.

Behind this phenomenal growth is the evolution of the robotics technology into maturity and economic feasibility. Systems are becoming more adaptable to individual needs. Applications are expanding outside of the operating room and into the home and research labs, allowing for greater possibilities and higher revenues. 

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Bausch and Lomb has announced a planned first quarter acquisition of cataract repair company Eyeonics, Inc. Eyeonics is known for the cystalens intraocular lens, which has been used for the treatment of cataracts in more than 95,000 eyes worldwide. 

Eyeonics, a privately held company based in Aliso Viejo Cali., generated approximately $34 million in revenues in 2007.  The company will become a part of Bausch & Lomb’s surgical business under J. Andy Corley, eyeonics’ co-founder, chairman, and CEO.

A new stent system developed by CeloNova BioSciences, Inc. is promising answers to current problems with stents.  The CATANIA ™ Stent System with NanoThin Polyzene®-F, called “The CAT” by cardiologists who have utilized it, offers a cost-effective and safe alternative to help patients with drug-eluting stents avoid the risk of stent thrombosis. 

According to Corrado Tamburino, MD and President of the Italian Society of Interventional Cardiology, angioplasties performed using the new product show no sign of thrombosis, low binary restenosis, and no MIs. 

Additional advantages to using the new product include early and complete vessel healing, discontinued dual anti-platelet therapy after only one month, and a bacterial-resistant surface treatment.

Mortality rates for patients with multiple blocked arteries are lower if they undergo coronary artery bypass surgery, rather than opting for multiple stents, according to a large-scale study published in this week’s New England Journal of Medicine. The study showed that for patients with two clogged arteries, the death rate over the next 18 months among those who had coronary bypass surgery was close to 30% lower than among those opting for the insertion of drug-eluting stents.

Over the last few years, angioplasty has become significantly more popular than bypass.

Women undergoing breast surgery have a more than 5% chance of developing surgical site infections, according to a study published in the January issue of Archives of Surgery. Such infections could result in hospital bills exceeding $4,000, researchers at the Washington University School of Medicine said. On average, it took 47 days after surgery for the diagnosis of an infection to be made.

The researchers added that the incidence of infection could be lowered by measures including “strategies to optimize the timing and dosage of prophylactic antibiotics administered before the surgical incision, glucose control in diabetic patients, promotion of meticulous hand hygiene, and strategies to promote timely removal of drains.”

The U.S. Food and Drug Administration (FDA) has expanded the indication for a liquid fibrin sealant to help control bleeding during general surgery. Fibrin is a protein that helps blood clot.

The sealant, called Evicel, which is manufactured by OMRIX Biopharmaceuticals, is sprayed or dripped on small, oozing blood vessels. Once applied, it forms a covering that helps stop bleeding. Evicel was previously approved for use during liver and vascular surgery. This approval expands Evicel’s indication to include general surgery applications.

A study of 135 patients undergoing abdominal surgery showed Evicel to be safe and effective in controlling bleeding. Adverse events reported during the clinical trial included anemia, abdominal abscess, blockage of the small intestine, and loss of urinary bladder tone, when the urinary bladder does not empty effectively, which can cause discomfort and infection.

FDA approved Evicel’s predecessor (Crosseal) in 2003 for use during liver surgery. It became Evicel in May 2007 when FDA expanded the indication to include use during vascular surgery.

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Voluven, an intravenous synthetic starch solution, has received FDA approval for use in surgery as a blood volume expander. Blood volume expanders are used to quickly restore some of the blood volume lost during surgery so that remaining red blood cells can continue to deliver oxygen to the body’s tissues. Voluven is manufactured by Fresenius Kabi, a German company.

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