1. XpandOrtho wins FDA 510(k) clearance
XpandOrtho announced in a May 17 press release that it has received FDA 510(k) clearance for its electronic soft tissue balancing instrument for total knee replacement surgery. The sterile-packaged wireless disposable device uses miniature sensors and actuators to balance knee joints during full-range motions. Using constant pressure bellows systems, the device communicates with a display for multiaxial balance and selection of thickness and tibial component.
2. Visionsense goes after Novadaq patent
Visionsense has filed an IPR with the USPTO for its Novadaq Technologies’ U.S. patent, according to a May 16 press release. The patent is for a method for using fluorescence angiography to assess patency of vessel grafts. It is the only patent that Novadaq lists on its website as being associated with the SPY Elite system.
3. FDA clears Body Vision Medical’s LungVision navigation system
Body Vision Medical announced in a May 15 press release that it received FDA clearance to market its LungVision imaging system that enables accurate, real-time navigation and lesion localization during bronchoscopy procedures. LungVision has gone through clinical trials in the U.S., where it has been shown to be a sophisticated augmented reality approach for physicians to visualize, plan and track endobronchial tools and radiolucent lesions in real-time. The system also uses intraoperative fluoroscopy and pre-operative high-resolution imaging.
4. Rivanna Medical touts Accuro spinal navigation data
Rivanna Medical is touting data from its Accuro automatic spinal navigation system trial, according to a May 15 press release. The Accuro navigation system enhances the accuracy of epidural and spinal anesthesia placement for residents-in-training and patients with atypical spinal anatomy. The randomized trial was conducted at the University of Virginia and compared anesthesiology residents’ success placing spinal anesthesia in C-section patients using Accuro with traditional methods. The trial showed that residents who had prior spinal anesthesia experience had improved first-attempt needle placement using Accuro. First-attempt needle placement improved more than 100% in patients with a high body mass index. The second clinical trial, held at Stanford University, showed that Accuro identified appropriate spinal interspace for needle insertion in 94% of patients and was 87% successful in first-attempt epidural administration. The third trial, at Rutgers University, showed that Accuro successfully identified bony landmarks and the optimal spinal interspaces for anesthesia delivery.
5. Exactech gets 510(k) clearance for computer-aided shoulder arthroplasty technology
Exactech announced in a May 15 press release that it has received FDA 510(k) clearance to market its ExactechGPS Shoulder Application. Exactech combines preoperative planning with computer-assisted surgery for greater intraoperative visibility in both standard and challenging shoulder arthroplasty. It is designed to be a preoperative planning tool to help surgeons understand patient anatomy before surgery. It allows for visibility into the glenoid vault in real-time and allows physicians to have consistent and accurate glenoid placement.
6. NxThera touts 2-year Rezum prostate treatment
NxThera announced the 2-year outcome data for its Rezum System clinical trial to treat lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia, according to a May 15 press release. The study showed that there was significant LUTS relief that stayed durable 2 years after treatment. 197 patients were enrolled in the study. The data showed durable symptom reduction and preserved sexual function in patients who were treated with Rezum.
7. Lombard launches Altura registry study
Lombard Medical announced in a May 15 press release that it has enrolled and treated the first patient in its global registry to evaluate Altura Endograft System. The study is being conducted on 1,000 patients in clinical use conditions. Altura Endograft System study is designed to study the impact on the treatment of abdominal aortic aneurysms using a D-stent EVAR design.