Bulletin Board - FDA News, November 2012

FDA Approves First Subcutaneous Heart Defibrillator

On September 28, 2012, the FDA approved the Subcutaneous Implantable Defibrillator System (S-ICD), a device for restoring regular heart rhythms with leads that can be implanted just under the skin, rather than connected directly into the heart. Other implantable defibrillators require a physician to insert one or more leads (ie, electrical conductor wires) into a patient’s vein in their upper chest and guide them into the patient’s heart using X-ray fluoroscopy. The S-ICD is different because it can be implanted under the skin, along the bottom of the rib cage and breastbone, with no wires implanted in the heart and no need for fluoroscopy.

Arrhythmias are very common in the elderly population, and a significant number of patients with these disorders require implantation of a cardiac rhythm device. “The S-ICD System provides an alternative for treating patients with life-threatening heart arrhythmias for whom the routine ICD placement procedure is not ideal,” said Christy Foreman, director of the Office of Device Evaluation, FDA Center for Devices and Radiological Health, in a press statement. “Some patients with anatomy that makes it challenging to place one of the implantable defibrillators currently on the market may especially benefit from this device.” The device is approved only for use in patients who do not require a pacemaker or pacing therapy.

The FDA approved S-ICD following a review of data from a 321-patient study in which 304 patients were successfully implanted with the device. Its safety and efficacy were tested by inducing abnormal heart rhythms in the study patients; the system successfully converted all arrhythmias back to normal rhythm, or these arrhythmias resolved on their own.

The most common complications that occurred with device implantation were inappropriate shocks, discomfort, system infection, and electrode movement that required repositioning. At the 6-month follow-up, more than 90% of the group experienced no complications. Eight patients died during the study period, however, researchers (who were independent of the study) could not attribute their deaths to the S-ICD system. As a condition of FDA-approval, S-ICD manufacturer Cameron Health Inc will conduct a 5-year post market study of 1600 patients to assess the long-term safety and performance of the device as well as potential differences in its efficacy between men and women. Learn more about the product at www.cameronhealth.com.

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 FDA Expands Use of SAPIEN Artificial Heart Valve to High-Risk Patients

On October 19, 2012, the FDA expanded the indication for the SAPIEN Transcatheter Heart Valve (THV) to include patients with severe symptomatic aortic stenosis who are eligible for surgery, but who are at high risk of surgical complications or death. The SAPIEN THV was first approved in November 2011 only for the treatment of inoperable patients, who received the device using a transfemoral approach. “With the addition of high-risk patients to those eligible for the transcatheter procedure and with the approval of the transapical approach, a considerably broader group can now be treated with the SAPIEN valve,” said SAPIEN manufacturer Edwards Lifesciences in a press statement.

The safety and efficacy of SAPIEN in high-risk patients were evaluated in a high-risk cohort (Cohort A) of the PARTNER Trial. Cohort A compared the outcomes of patients at high risk for open heart surgery (predictive operative mortality rate of ≥15%) to receive either surgical aortic valve replacement (n=351) or the SAPIEN THV (n=3481) via transfemoral or transapical delivery. The survival rates among both groups were comparable at 1 month, 1 year, and 2 years after the procedures.

Transcatheter aortic valve replacement is a minimally invasive procedure in which the SAPIEN THV takes the place of a patient’s diseased valve and is immediately functional. The device is contraindicated in patients who cannot tolerate anticoagulation therapy. Those who received the SAPIEN THV showed an increased risk for major vascular complications, such as artery dissection or perforation, and for stroke in the month following the procedure, but are less likely to experience major vascular bleeding during the procedure. The device will continue to be evaluated by Edwards Lifesciences through a national Transcatheter Valve Therapy registry. To learn more about the SAPIAN THV, visit www.edwards.com/products/transcathetervalve/Pages/THVcategory.aspx.

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FDA Approves Jetrea for Symptomatic Vitreomacular Adhesion in the Eyes

On October 17, 2012, the FDA approved Jetrea (ocriplasmin), the first drug approved to treat symptomatic vitreomacular adhesion (VMA), a sight-threatening eye condition characterized by the vitreous pulling away from the macula. As the eye naturally ages, the vitreous separates from the retina; however, if the two do not completely separate from one another, this can cause a pulling force on the retina that may result in vision loss or distortion.

Given by intravitreal injection, Jetrea is a proteolytic enzyme that works to break down the excess proteins that cause the abnormally strong attachment between the vitreous and macula in patients with VMA. When these proteins are broken down, it allows for a better possibility of the natural separation to occur with little or no tugging and tearing on the macula. Without this enzyme, the standard of care for treating patients with VMA is vitrectomy, a surgical removal of the vitreous gel from the middle of the eye.

The safety and efficacy of Jetrea were based on two multicenter, double-blind studies involving 652 patients with VMA who were randomly assigned to receive a single injection of Jetrea or placebo. At the 6-month follow-up, the trials found that VMA had resolved in 26% of patients treated with Jetrea, compared with 10% of the placebo group. The most commonly reported adverse effects included eye floaters, bleeding of the conjunctiva, eye pain, photopsia, blurred vision, unclear vision, vision loss, retinal edema, and macular edema. No significant differences in efficacy or safety were seen in adults aged 65 years or older. Learn more about Jetrea at https://jetrea.com.

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FDA Announces Initiative to Combat Antibiotic Resistance

On September 24, 2012, the FDA announced the formation of the Antibacterial Drug Development Task Force, a multidisciplinary group comprised of 19 scientists and clinicians who will assist in developing and revising guidance related to antibacterial drug development. According to statistics from the FDA, more than 70% of the bacteria that cause hospital-acquired infections (HAIs) are resistant to at least one type of antibacterial drug most commonly used to treat these infections. Antibiotic resistance has become a major national health concern due to the increasing frequency of HAIs, and elderly persons residing in long-term care are
especially susceptible to HAIs.

The task force will work together to identify potential breakthroughs in the field of antibacterial drug development to help reduce antibacterial drug resistance. “The creation of this new task force comes at a critical time,” said Edward Cox, MD, director of the Office of Antimicrobial Products, FDA Center for Drug Evaluation and Research (CDER) and co-chair of the task force, in a press statement. “Establishing new ways of developing safe and effective new antibacterial drugs is an enormous challenge and not an effort that can be accomplished alone.”