Commercial Launch of Xact Device Undewsay

OrthoNext Digital Platform for the JuniOrtho Plating System Receives FDA Clearance

“Together, OrthoNext and the JuniOrtho Plating System provide a complete solution for surgeons looking for a plating system to address the specific demands of advanced deformity and trauma reconstruction of the lower extremities in the pediatric population,” said Orthofix President of Global Orthopedics Paul Gonsalves.

SonarMed, New Pediatric Monitor Alerts Clinicians To Potential Airway Obstructions During Ventilation Launched

"The SonarMed airway monitoring device has revolutionized the way we care for our littlest patients. There is no other device in the world that can tell you where the endotracheal tube is located within the airway continuously in real-time, and whether the tube is obstructed or even partially occluded," said Jamie W. Powers, M.D., MBA, neonatologist at Huntington Hospital in Pasadena, California.

Cypris Medical, Inc. announced today the commercial release of its Xact device for minimally invasive face and neck lift suturing.

“I’m excited that Cypris Medical is the first to effectively address a sizable unmet need in facial aesthetics,” said Dan Holton, Chief Executive Officer. “The first application of our Xact technology is designed to provide surgical outcomes of gravitational descent in the face and neck via a minimally invasive procedure. The device has already developed a strong patient satisfaction track record. It’s a favorable solution for the millions of patients who need more than neurotoxins and fillers, but don’t want to undergo a full face or neck lift.” He added, “The technology is the first of its kind in plastic surgery and is being extended to additional applications currently under development. We are incredibly proud to spearhead a new generation of minimally invasive plastic surgery.”

The Xact suturing device achieved FDA clearance in April 2017. The commercial launch follows a successful evaluation period in which patients demonstrated satisfying, lasting results over two years. Procedures that use Xact are well suited to be performed without general anesthesia in out-patient settings. Procedures can be completed in less than an hour. Patients typically recover in five days or less. Comparatively, traditional facelift, browlift and necklift surgical treatments require general anesthesia and longer recovery time.

“Minimally invasive options are becoming the standard in surgical procedures throughout medicine. It’s time for plastic surgery to advance, and the Xact device is well equipped to pioneer that shift,” said Dr. Louis Bucky, a board-certified plastic surgeon, who serves on the Cypris Medical Advisory Board.

“Xact technology will absolutely transform our industry’s treatment of facial aging,” said Dr. Christopher Godek, a board-certified plastic surgeon and lead clinical investigator for Xact. “This innovation can replace previous technologies, such as thread lifts, which have proven ineffective due to imprecise anatomic targets, limited longevity and high complication rates including thread extrusion. The Xact device effectively extends a surgeon’s hands into hard-to-reach areas. Utilizing small, two-centimeter-long incisions hidden within the hairline, surgeons can accurately and precisely lift, reposition and suture tissue.”

Xact is a hand-held surgical suturing device designed to approximate and passsuture through soft tissue. Xact extends a surgeon’s hands allowing them to place sutures precisely with less tissue disruption. This makes procedures that use Xact less invasive which speeds recovery time. Xact can be used in any procedure that requires precise delivery of a suture.

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