August 7, 2017
Fresenius Medical Care to Acquire NxStage Medical
Fresenius Medical Care announced that it has signed an agreement to acquire all outstanding shares of NxStage Medical through a merger for $30.00 per common share for a total value of approximately $2.0 billion. Fresenius Medical expects the transaction to be cash and debt financed and produce an initial net cost synergies potential of approximately USD 80 to 100 million p.a. before tax over three to five years. The Company also expects the acquisition to be accretive to net income and EPS within three years from closing. The merger, which has been approved by NxStage's board and is expected to close in 2018, is subject to approval of NxStage stockholders, receipt of regulatory approvals and other customary closing conditions.
Fresenius develops, produces and markets a product portfolio of medical devices for use in home dialysis and in the critical care setting. NxStage Medical develops, manufactures and markets products for the treatment of end-stage renal disease (ESRD) and acute kidney failure. NxStage Medical’s primary product, the NxStage System One, is a small, portable hemodialysis system designed to provide physicians and patients improved flexibility in the way hemodialysis therapy is prescribed and delivered in clinical settings. NxStage has also developed the Streamline Express, a dialyzer for the in-center hemodialysis market, and the OneSite Dual Lumen Needle, a vascular access device for dialysis procedures.
August 8, 2017
ApiFix System Granted Regulatory Approval in Australia
ApiFix announced that it has been certified by the Therapeutic Goods Administration (TGA), through its distributor Orthotech, to begin marketing the ApiFix system in Australia for the treatment and correction of Adolescent Idiopathic Scoliosis (AIS) using a minimally invasive surgical approach.
The ApiFix system treats adolescent idiopathic scoliosis (AIS) patients with deformity classified as Lenke type 1 and 5 and a Cobb angle from 40 to 60 degrees. The system is comprised of a minimally invasive, non-fusion spinal implant system which maintains spine flexibility and improves the quality of life of patients who undergo scoliosis surgery. The small implant is attached to the spine at the apex of the major curve using only two screws. This is a short and comparatively simple procedure that takes about one hour, being considerably more cost-effective than current scoliosis surgery by saving hospitalization and operating room (OR) time. On completion of the procedure, the patient returns home after a short hospitalization period (2-3 days). The ApiFix System received CE Mark approval in 2015 and was launched in Europe with the first completed correction surgery in Barcelona in July 2017.
See more on the ApiFix System on Meddevicetracker.
August 9, 2017
Indian Regulators Reiterate ABSORB BVS Safety Warning
Amid safety concerns that arose from data unveiled in March 2017 at the American College of Cardiology (ACC), the Drug Controller General of India (DCGI) echoed warnings on using Abbott’s ABSORB Bioresorbable (BVS) Stent in too-small coronary vessels. The ABSORB GT1 BVS System is a drug/device combination product consisting of a balloon dilatation catheter, an absorbable polymeric scaffold, and a drug-eluting coating composed of a mixture of poly (DL-lactide) (PDLLA) absorbable polymer and everolimus anti-proliferative/immunosuppressant drug.
The data unveiled at ACC showed that ABSORB confers a higher risk of serious adverse events at two years compared with the company’s Xience drug-eluting stent, according to data from a study that prompted the U.S. Food and Drug Administration (FDA) to warn physicians on the risk. In response to this data, Abbott curtailed use of the device in Europe. In a letter to physicians dated March 31, 2017, Abbott said it would restrict use of the Absorb and Absorb GT1 devices to clinical registry studies starting May 31, 2017. The FDA said it’s investigating the higher adverse event rate for Absorb, which it approved in July 2016 with the proviso that Abbott run a 5-year post-market study of the device. The stent was approved via the Premarket Approval (PMA) pathway, using data from the pivotal ABSORB-III study, which compared the rate of major adverse cardiac events between the Absorb GT1 BVS and a Xience drug-eluting metallic stent. The issue prompted the Drug Controller General of India to warn against using the Absorb devices in blood vessels smaller than 2.5mm. The stents can be used in larger vessels under controlled conditions. An Abbott spokesperson mentioned that it's in talks with India’s Central Drugs Standard Control Organization “on an ongoing basis” and that it has already submitted a plan for clinical follow-up of existing ABSORB patients in India.
See more on the ABSORB BVS on Meddevicetracker.
August 10, 2017
FDA Issues Safety Update on ORBERA and ReShape Duo Intragastric Balloons
Apollo EndoSurgery announced that the U.S. Food and Drug Administration (FDA) issued an update to alert health care providers of five reports of unanticipated deaths that occurred from 2016 to present in patients with liquid-filled intragastric balloon systems used to treat obesity. Four reports involve the Apollo’s ORBERA Intragastric Balloon System and one report involves ReShape Medical’s ReShape Duo Integrated Dual Balloon System. ORBERA is a non-pharmaceutical, non-surgical aid designed to assist weight loss by partially filling the stomach. The intragastric balloon consists of a soft, smooth silicone elastomer balloon that is placed in the stomach endoscopically and filled with saline, causing it to expand into a spherical shape. The filled balloon is designed to occupy space and move freely within the stomach. ReShape Duo is a non-surgical, dual-intragastric balloon treatment also designed for weight loss. The device is placed into the stomach during a 15-30 minute, non-surgical, outpatient procedure using an endoscope that is inserted through the mouth into the stomach while the patients is under conscious sedation. The un-inflated balloons are advanced over a guidewire and are precisely placed in the stomach. Each balloon is inflated with saline and independently sealed. The device is released and remains in the stomach for six months, serving as built-in portion control.
All five reports indicate that patient deaths occurred within a month or less of balloon placement. In three reports, death occurred as soon as one to three days after balloon placement. At this time, the FDA does not know the root cause or incidence rate of patient death, nor has it been able to definitively attribute the deaths to the devices or the insertion procedures for these devices (e.g., gastric and esophageal perforation, or intestinal obstruction). The FDA has also received two additional reports of deaths in the same time period related to potential complications associated with balloon treatment (one gastric perforation with the ORBERA Intragastric Balloon System and one esophageal perforation with the ReShape Duo Integrated Dual Balloon System). In February 2017, the FDA issued a letter to health care providers to recommend close monitoring of patients with liquid-filled intragastric balloon systems used to treat obesity for the potential risks of acute pancreatitis and spontaneous over-inflation. Since issuing this letter, both companies have revised their product labeling to address these risks. Apollo Endosurgery, ReShape Medical, and the FDA are working together to better understand these issues.