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FDA approves novel device Zephyr Endobronchial Valve (Zephyr Valve) for treating breathing difficulty from severe emphysema
Depiction of the Zephyr ® endobronchial valve. Image courtesy of Pulmonx, Inc.
The U.S. Food and Drug Administration today approved a new device, the Zephyr Endobronchial Valve (Zephyr Valve), intended to treat breathing difficulty associated with severe emphysema.
June 29, 2018
Release
The U.S. Food and Drug Administration today approved a new device, the Zephyr Endobronchial Valve (Zephyr Valve), intended to treat breathing difficulty associated with severe emphysema.
“Treatment options are limited for people with emphysema who have severe symptoms that have not improved from taking medicines. These have included lung surgery, such as lung volume reduction or lung transplants, which may not be suitable or appropriate for all patients,” said Tina Kiang, Ph.D., acting director, Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices, in the FDA’s Center for Devices and Radiological Health. “This novel device is a less invasive treatment that expands the options available to patients.”
The Centers for Disease Control and Prevention estimates that 3.5 million American adults have been diagnosed with emphysema. Emphysema, including severe emphysema, is a type of chronic obstructive pulmonary disease (COPD) due to damage to the air sacs (alveoli) in the lungs. Lung damage from emphysema is irreversible. The damaged alveoli can cause used air to become trapped in the lungs during exhalation. This can cause the diseased parts of the lung to get larger and put pressure on the healthy part of the lung, which makes it difficult to breathe. As a result, the body may not get the oxygen it needs.
Using a flexible bronchoscope, a doctor places Zephyr Valves, similar in size to pencil erasers, into the diseased areas of the lung airways during a procedure in a hospital setting. Design of the device is intended to prevent air from entering the damaged parts of the lung and allow trapped air and fluids to escape. During inhalation, the valves close, preventing air from entering the damaged part of the lung and during exhalation, the valves open, letting out trapped air, which is intended to relieve pressure.
The FDA reviewed data from a multi-center study of 190 patients with severe emphysema. In this study, 128 patients were treated with Zephyr Valves and medical management according to current clinical guidelines, including medications (bronchodilators, corticosteroids, antibiotics or anti-inflammatory maintenance medications) and pulmonary rehabilitation, while 62 patients (the control group) received medical management only. Results of treatment were measured by how many patients in each arm of the study had at least a 15 percent improvement in pulmonary function scores (the volume of air that can forcibly be blown out in one second after full inhalation). At one year, 47.7 percent of patients treated with Zephyr Valves experienced at least a 15 percent improvement in their pulmonary function scores, compared with 16.8 percent of patients in the control group. Adverse events observed in the study include death, air leak (pneumothorax), pneumonia, worsening of emphysema, coughing up blood, shortness of breath and chest pain.
The Zephyr Valve device is contraindicated for patients with active lung infections; those who are allergic to nitinol, nickel, titanium or silicone; active smokers and those who are not able to tolerate the bronchoscopic procedure. Patients who have had major lung procedures, heart disease, large bubbles of air trapped in the lung or who have not responded to other treatments should talk with their providers to determine if the Zephyr Valve device is appropriate for them.
The Zephyr Valve was granted Breakthrough Device designation, meaning the FDA provided intensive interaction and guidance to the company on efficient device development, to expedite evidence generation and the agency’s review of the device. To qualify for such designation, a device must provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition, and meet one of the following criteria: the device must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives; or the availability of the device is in the best interest of patients.
The FDA reviewed the Zephyr Valve device through the premarket approval review pathway, a regulatory pathway for the highest risk class of devices.
The FDA granted approval of the Zephyr Valve device to Pulmonx Inc.
FDA Approves First Device to Prevent Migraines
TUESDAY March 11, 2014, 2014 — The U.S. Food and Drug Administration on Tuesday approved the first device aimed at preventing migraines.
The device, called Cefaly, is a headband-like device that runs on a battery and sits across the forehead and over the ears, the FDA said in a statement.
“The user positions the device in the center of the forehead, just above the eyes, using a self-adhesive electrode,” the agency explained. “The device applies an electric current to the skin and underlying body tissues to stimulate branches of the trigeminal nerve, which has been associated with migraine headaches.”
Cefaly is made by Belgium-based Cefaly Technology and is available by prescription only. The device is only indicated for use by adults and should only be used for 20 minutes per day, the FDA said. The agency also noted that “the user may feel a tingling or massaging sensation where the electrode is applied.”
CEFALY DRUG-FREE MIGRAINE PAIN RELIEF
Cefaly offers patients suffering from migraine pain and headaches an efficient electrotherapeutical system delivered via an extremely comfortable, ergonomic and simple-to-use medical device.
Roche wins FDA approval for novel diabetes Dx
Roche’s next-generation diabetes diagnostic works on the Cobas Integra 800 analyzer. –Courtesy of Roche
Read more: Roche wins FDA approval for novel diabetes Dx – FierceMedicalDevices
NOVARTIS TOBI Podhaler receives FDA approval for cystic fibrosis patients with Pseudomonas aeruginosa
Tobramycin
MAR 22.2013, FDA approves TOBI Podhaler to treat a type of bacterial lung infection in cystic fibrosispatients
The U.S. Food and Drug Administration today approved TOBI Podhaler (tobramycininhalation powder) for the management of cystic fibrosis patients with Pseudomonas aeruginosa, a bacterium that causes lung infections.
Cystic fibrosis is a genetic disease that affects about 30,000 pediatric and adult patients in the United States. Cystic fibrosis causes the body to produce thick, sticky mucus that builds up in the lungs and blocks airways. The buildup of mucus makes it easy for bacteria like P. aeruginosa to grow and cause a chronic lung infection that, over time, can severely damage the lungs. Many patients with cystic fibrosis are treated with antibiotics using a nebulizer machine.
Tobramycin is an aminoglycoside antibiotic derived from Streptomyces tenebrarius and used to treat various types of bacteria infections, particularly Gram-negative infections. It is especially effective against species of Pseudomonas.
TOBI Podhaler, a plastic, handheld inhaler device, contains a dry powder formulation of tobramycin, an antibiotic used to treat P. aeruginosa infection. The powder is inhaled twice daily using the Podhaler device for 28 days. Patients should then stop TOBI Podhaler therapy for 28 days before resuming again.
“Today’s approval broadens the available delivery mechanism options for patients withcystic fibrosis who require treatment for P. aeruginosa,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “This product is the first dry powder antibacterial drug delivered with a handheld dry powder inhaler.”
Vital 5 Receives Clearance from the FDA for a First-To-Market, Dual Function Catheter System that Provides Simultaneous Anesthetic Infusion and Wound Drainage, ReLeaf™
Mar 6, 2013 ,
Vital 5, LLC, a VentureMD portfolio company, announces that it has received clearance from the U. S. Food and Drug Administration (FDA) for ReLeaf™, a first-to-market, dual function catheter system that provides simultaneous anesthetic infusion and wound drainage.
Continuous anesthetic infusion to the surgical site in the immediate post-operative period has been clinically proven to provide significant improvements to pain management, but this therapy is currently not compatible with the millions of surgical cases where a wound drain is prescribed. By offering an integrated system that provides effective continuous local anesthetic infusion while also providing an effective wound drain function, the Vital 5 ReLeaf will greatly expand the number of patients who can benefit from local anesthetic infusion therapy.
The clinical applications for the Vital 5 ReLeaf include any invasive surgical procedure, including spine, orthopedic, cardiothoracic, plastic, general, obstetrics and gynecological procedures.
About Vital 5, LLC
Vital 5 is an early stage medical device company focused on developing advanced catheter technologies to meet the increasing demand for improved post-operative pain management.
About VentureMD
VentureMD (venturemd.com) is an angel capital firm and medical device incubator focused on musculoskeletal products. The company provides financial, human and intellectual capital to start-up medical device companies. Focused on the orthopedic, spine, endoscopy and dental markets, the company partners with entrepreneurs, inventors, technology transfer offices and seed stage start-ups to launch and manage new medical device companies.
Phase III Study of Teva’s Milprosa (Progesterone) Vaginal Ring Published in Fertility and Sterility
Progesterone
Data Demonstrated Once-Weekly Milprosa™ Provides Similar Pregnancy Rates to Daily 8 Percent Progesterone Vaginal Gel
Mar 4, 2013 –
Teva Pharmaceutical Industries Ltd. today announced the publication of results of the Phase III clinical trial of Milprosa™ (progesterone) vaginal ring in Fertility and Sterility. The study compared the efficacy and safety of once-weekly Milprosa™ to daily 8 percent progesterone vaginal gel for luteal phase support in in vitro fertilization (IVF) and found that clinical pregnancy rates per retrieval at eight and 12 weeks were comparable between patient groups. Adverse event (AE) profiles were similar between the two treatment groups and consistent with known AEs associated with progesterone.
“The study results demonstrate that Milprosa™ may be an effective and safe option for progesterone supplementation during the luteal phase among women undergoing IVF,” said Laurel Stadtmauer, M.D., Ph.D., professor of Obstetrics and Gynecology at Jones Institute for Reproductive Medicine at Eastern Virginia Medical School and study author. “Since normal luteal function may be compromised among women undergoing IVF, progesterone supplementation is essential and the more options patients have, the better. If approved, the once-weekly dosing of Milprosa™ may offer convenience for patients.”
The Phase III randomized, single-blinded, multicenter, noninferiority study was conducted at 22 clinical sites in the U.S. and included 1,297 patients between the ages of 18 and 42. Of enrolled patients, 646 were randomized to Milprosa™ and 651 to the 8 percent progesterone vaginal gel.
“The Fertility and Sterility publication of the Milprosa™ Phase III data is a significant milestone for Teva, especially because fertility is a meaningful new area of specialization for the company and one in which significant unmet need exists,” said Jill DeSimone, senior vice president & general manager, Global Teva Women’s Health. “We look forward to continuing to share important updates about Milprosa™ and demonstrating our investment in and commitment to women’s health.”
About the Study
The Phase III study randomized patients into two treatment groups: one group received once-weekly Milprosa™ and the other received daily 8 percent progesterone vaginal gel. Milprosa™ and the vaginal gel were initiated on the day following egg retrieval and continued through 12 weeks’ gestation. Efficacy was evaluated by comparing clinical pregnancy rates of patients at eight and 12 weeks gestation.
- At week eight, clinical pregnancy rates per retrieval were 48.0 percent for the Milprosa™ group and 47.2 percent for the vaginal gel group (between-group difference, 0.8%; 95% CI, -4.6%, 6.3%).
- At week 12, clinical pregnancy rates per retrieval for Milprosa™ and the vaginal gel were 46.4 percent and 45.2 percent respectively (between-group difference, 1.3%; 95% CI, -4.1%, 6.7%).
A secondary efficacy endpoint was the rate of live birth.
- The overall live birth rate per retrieval for women using Milprosa™ was 45.2 percent; among women using the vaginal gel, the rate was 43.3 percent.
- The majority of patients pregnant at week 12, when progesterone treatment ended, went on to have a live birth: 97.4 percent for the Milprosa™ group and 96.5 percent for the vaginal gel group.
The most commonly reported adverse events (those greater than or equal to 10% in the Milprosa™ treatment group) were nausea, headache, abdominal pain, post-procedural discomfort, abdominal distension, back pain, fatigue, vomiting and constipation. Serious adverse events (SAEs) occurred in approximately 12 percent of all patients, with no significant difference in the rate between treatment groups. The majority of SAEs that occurred were mild to moderate in severity and not related to treatment. Rates of discontinuation of treatment due to AEs were low and similar between both groups (approximately 6%).
About Milprosa™ (Progesterone) Vaginal Ring
Milprosa™ is an investigational, once-weekly progesterone ring inserted in the vagina. It is flexible and designed to continuously release a steady dose of micronized progesterone. Milprosa™ is in development to support embryo transplantation and early pregnancy (up to 10 weeks post-embryo transfer) by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.
About Supplementation of Corpus Luteal Function
The corpus luteum is a temporary endocrine gland that develops during the luteal phase of a woman’s menstrual cycle. It is an important contributor of progesterone and is critical for the maintenance of early pregnancy. During in vitro fertilization, progesterone supplementation is needed because natural levels of the hormone may be insufficient. This supplementation improves implantation rates and thus pregnancy rates. Additionally, progesterone supplementation supports early pregnancy.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world’s leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in about 60 countries. Teva’s branded businesses focus on CNS, oncology, pain, respiratory and women’s health therapeutic areas as well as biologics. Teva currently employs approximately 46,000 people around the world and reached $20.3 billion in net revenues in 2012.
FDA Approves Natrelle 410 Breast Implant
Silicone gel-filled breast implants
Image/FDA
Feb. 20, 2013
The U.S. Food and Drug Administration (FDA) approved Allergan’s new silicone gel-filled breast implant today, making it the fourth FDA-approved silicone gel-filled breast implant product available in the U.S, according to an FDA news release Feb. 20.
The product, the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant, can be used increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age.
According to the FDA, the approval is based on seven years of data from 941 women. Most complications and outcomes reflect those found in previous breast implant studies including tightening of the area around the implant (capsular contracture), re-operation, implant removal, an uneven appearance (asymmetry), and infection.
It’s important to remember that breast implants are not lifetime devices. Women should fully understand the risks associated with breast implants before considering augmentation or reconstruction surgery, and they should recognize that long-term monitoring is essential,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.
“The data we reviewed showed a reasonable assurance of safety and effectiveness,” said Shuren.
The FDA requires that Allergan conduct a series of post-approval studies to assess long-term safety and effectiveness outcomes and the risks of rare disease.
FDA approves first retinal implant for adults with rare genetic eye disease
Argus II (credit: Second Sight)Second Sight Medical Products, Inc., is the manufacturer and is already approved in Europe
Argus II components (credit: FDA)
The Argus II design consists of an external video camera system matched to the implanted retinal stimulator, which contains a microelectrode array that spans 20 degrees of visual field.
An external camera system, built into a pair of glasses, streams video to a belt-worn computer, which converts the video into stimulus commands for the implant.
The belt-worn video processing unit (computer) encodes the commands into a wireless signal that is transmitted to the implant, which has the necessary electronics to receive and decode both wireless power and data.
Artificial retina device, consisting of a glasses-mounted camera and a microchip surgically implanted on the retina
Based on those data, the implant stimulates the retina with small electrical pulses. The electronics are hermetically packaged and the electrical stimulus is delivered to the retina via a microelectrode array.
Medical Device Using Evonik’s VESTAKEEP® PEEK Receives First FDA Spinal 510(K) Approval
VESTAKEEP® PEEK are aromatic polyetheretherketone molding compounds for manufacturing long-lasting components that you can use under the toughest conditions. Our base VESTAKEEP® PEEK grades come in a wide range of viscosities, and we have standard molding compounds modified by various additives.
K7 LLC’s K7C™ Cervical Spacer, a spinal implant device using Evonik’s VESTAKEEP® PEEK (polyetheretherketone), has received the U.S. Food and Drug Administration’s (FDA) 510(k) approval for use as an Intervertebral Body Fusion (IBF) device.
“Creating innovative solutions for our customers is a core component of Evonik”
This marks the first time a VESTAKEEP® PEEK-based spinal fusion medical device has gained 510(k) approval from the FDA. The K7C™ Cervical Spacer is one of several PEEK-based spinal implant devices being developed by K7 LLC.
Michael Smith, founder and CEO of K7 LLC attributed VESTAKEEP® PEEK’s durability as a key component in gaining FDA 510(k) clearance. “We could not be more pleased with the test results and material durability of VESTAKEEP® PEEK,” said Smith. “The inherent strength and added ductility have created new possibilities for our PEEK implant designs.”
Evonik’s customers can reference the VESTAKEEP® PEEK product line Masterfiles (MAF), documents containing comprehensive test data on the product’s mechanical and biocompatible properties that meet FDA regulatory requirements, to help guide future registration processes for implant medical devices.
“Creating innovative solutions for our customers is a core component of Evonik,” said Sanjeev Taneja, vice president of Evonik’s High Temperature Polymers Business. “The FDA approval is a testament to the product quality of VESTAKEEP® PEEK and the strength of its MAF. It is also an example of the long-term commitment Evonik has in the medical device and orthopedic industries. This approval validates Evonik as a true player in the implant PEEK market.”
VESTAKEEP® PEEK is known for its superior biocompatibility and biostability. Its excellent sterilization resistance and good combination of stiffness and ductility make it suitable for medical implant applications that must meet extremely high mechanical, thermal, and chemical requirements.
New Drug Approvals 