Surgical Anesthetic: Intel for Your OR

Amneal

On August 20, 2024, Amneal Pharmaceuticals announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for Propofol Injectable Emulsion USP, 200 mg/20 mL (10 mg/mL), 500 mg/50 mL (10 mg/mL), and 1,000 mg/100 mL (10 mg/mL), Single-Dose Vials. This marks the expansion of Amneal’s injectable portfolio – and the offering of an essential surgical anesthetic in hospitals where there has been a chronic shortage.

This complex emulsion injectable is an intravenous drug commonly used in hospitals and surgery clinics for the induction and maintenance of anesthesia and sedation. It is currently on the American Society of Health System Pharmacists (ASHP) drug shortages list. In fact, Propofol has a history of shortage due to supply chain constraints. Consistently found on FDA and ASHP drug shortage lists, Propofol is now manufactured by Amneal on a dedicated, in-house line, ensuring consistent quality and availability.

“Amneal is keenly focused on delivering critical drugs that are in short supply,” said Andy Boyer, Executive Vice President, Chief Commercial Officer-Generics. “This single dose formulation of propofol is an essential medicine utilized every day by hospitals. We are proud to provide our hospital customers with this hard-to-make product and help patients in need. With our large global manufacturing footprint, Amneal aims to be the provider of choice for complex products like propofol.”

Propofol Injectable Emulsion, USP, comes in 20 mL, 50mL and 100 mL vials, and the 50mL and 100mL include vial label hangers. Propofol Injectable Emulsion, USP, is an intravenous general anesthetic and sedation drug indicated for induction of general anesthesia for patients greater than or equal to 3 years of age; maintenance of general anesthesia for patients greater than or equal to 2 months of age; initiation and maintenance of monitored anesthesia care (MAC) sedation in adult patients; sedation for adult patients in combination with regional anesthesia; and intensive care unit (ICU) sedation of intubated, mechanically ventilated adult patients.

Propofol is contraindicated in people who have known hypersensitivity to propofol, egg or soybean. For full prescribing information, see the package insert here.

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceuticals company. The company makes healthy possible through the development, manufacturing and distribution of a diverse portfolio of over 280 generic and specialty pharmaceuticals, primarily within the United States. In its Generics segment, the company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail and institutional markets. For more information, visit www.amneal.com.

From the perfect knotless suture anchors to augmented reality (AR) systems that provide surgeons with game-changing navigation guidance, orthopedics is a service line that’s synonymous with innovation.

Every year, astronomical sums of money are poured into the research and development of new technology and instrumentation that allows providers to do things that were deemed impossible in the not-to-distant past. The result? A market that’s teeming with products that make the millions of orthopedic cases performed at outpatient facilities each year more accurate, efficient and safe.

Here’s a sampling of the diversity inherent in the orthopedic solutions category.

Rotator Cuff Repair with a Tensionable Knotless Mechanism

Arthrex’s Knotless SwiveLock suture anchor for tensionable knotless soft-tissue repair is the most trusted universal and adaptable knotless suture anchor system on the market. Surgeons appreciate the unique tissue tear patterns while still achieving the core fixation from a SpeedBridge rotator cuff repair. Controlled tendon reduction under direct visualization using medial row tensionable knotless SwiveLock Suture Anchors:

• #2 Eyelet Suture for simple or mattress stitch knotless fixation
• Interconnected anchors for double-pulley knotless fixation.

For more information, visit Ad.Arthrex.com/SpeedBridge

Tech that Partners with Healthcare Professionals

The ARVIS Augmented Reality System brings the next era of orthopedic technology for total hip, total knee and uni-compartmental knee arthroplasty, according to Enovis, the company behind the AR system. This wearable, self-contained system delivers real-time, hands-free surgical guidance at the point of care. Cameras mounted at your viewpoint can track reusable markers on the patient to provide accurate navigation guidance.

For more information, visit www.enovis.com

New ECTR Disposable Blade Assembly Reinvents Value

Hand Biomechanics Lab offers a new Endoscopic Carpal Tunnel Release (ECTR) Disposable Blade Assembly system. This new – not refurbished – USA-made disposable blade assembly costs $545 per 6 pack, about half the price that most facilities are paying. This new drop-in replacement blade assembly is compatible with:

• 3M Agee Inside Job ECTR System
• MicroAire SmartRelease ECTR System

For more information, call (800) 522-5778, email [email protected] or visit www.handbiolab.com

Why It’s the Gold Standard in Bone Cement

Heraeus Medical’s PALACOS pro All-In-One Fixation System means success in joint replacement because PALACOS pro provides quality, consistency and innovation in orthopedic joint fixation and infection management. Studies comparing PALACOS with other bone cements show:

• 25% lower risk of revision for THA
• 8% better risk-adjusted survivorship in TKA
• 61% decrease in one-year infection rates for TKA
• 3 times fewer revisions for early aseptic loosening in TKA
• >50% decrease in revision risk in THR

For more information, call (833) PALACOS or visit www.PALACOS.com OSM