Novare Surgical Systems, Inc. was a medical technology company founded in 1999 and based in Cupertino, California, USA. The entity specialized in the development, manufacture, and marketing of proprietary surgical devices, initially focusing on products for traditional and minimally invasive cardiac procedures before shifting its core business to advanced instrumentation for laparoscopic (keyhole) and single-port access (SPA) minimally invasive surgery (MIS). Its primary contribution to the MedTech sector was the introduction of high-dexterity, hand-held instruments designed to overcome the dexterity limitations of conventional, rigid laparoscopic tools.
Core Business and Technology: High Dexterity Minimally Invasive Surgery
The central focus of Novare Surgical Systems' operations was its proprietary high-dexterity technology platform, known as RealHand High Dexterity (HD) Instruments. This technology was a breakthrough in non-robotic MIS, enabling surgeons to perform complex procedures with greater ease and control, offering an alternative to expensive master-slave robotic systems.
The company's mission in the MIS space was to facilitate "hidden scar surgery" by making Single Port Access (SPA) procedures???which involve a single, small incision, often hidden in the navel???more feasible and repeatable for surgeons.
Products and Services: RealHand HD Platform
The RealHand HD instruments represented the first line of hand-held laparoscopic instruments to offer full range-of-motion, mirroring the natural movement of the surgeon's wrist and hand inside the patient's body.
RealHand HD Instruments: These are a family of surgical tools developed with the proprietary EndoLink(R) mechanism. The instruments were designed to provide seven degrees of freedom of movement, a level of articulation previously only associated with robotic systems.
Functionality: Unlike standard straight laparoscopic instruments, RealHand HD allows for a wrist-like movement at the instrument's tip, dramatically improving the ability to maneuver around internal structures.
Key Advantage: The system translates the surgeon's natural, unrestricted hand motion directly into complex movements inside the patient, while also providing simultaneous tactile feedback, a critical factor in safe and precise surgery.
Applications: The instruments were cleared by the FDA for grasping, mobilization, dissection, transection, suturing, and/or electrocautery of tissue under direct and endoscopic visualization. They enabled Single Port Access surgery in various fields, including general surgery, gynecology (e.g., total laparoscopic hysterectomy), and urology (e.g., laparoscopic nephrectomy). The technology also supported complex procedures such as pediatric single-port splenectomies and co-developed cut-and-seal instruments for procedures like colectomy and bariatric surgery.
Specific RealHand Product Lines: The RealHand HD technology was integrated into various endo-laparoscopic instrument types, including:
Graspers
Dissectors
Scissors
Needle Drivers
Initial Business Focus: Cardiac Surgery Devices
Before its pivot to the high-dexterity MIS market, Novare Surgical Systems initially focused on developing devices for cardiac surgery. These products were rooted in the intellectual property and design principles of co-founder Thomas J. Fogarty, MD.
Cardiac Products and Devices
Enclose(R) / ENCLOSE II Anastomosis Assist Device:
Description: An assist device designed to help surgeons perform multiple proximal anastomoses during "off-pump" Coronary Artery Bypass Graft (CABG) surgery, also known as beating-heart surgery.
Purpose: The device provided a mechanical solution to assist in the highly delicate process of connecting a bypass graft to the coronary artery while the heart continues to beat, thereby avoiding the need for cardiopulmonary bypass (heart-lung machine) in select cases.
Intrack(R) Family of Atraumatic Occlusion Devices:
Purpose: This product family was developed to improve upon the traditional Fogarty clamp concept by creating atraumatic devices for cross-clamping and occlusion of blood vessels.
Specific Product Lines: The Intrack family included the Engage(R), Cygnet(R), Novaclip(R), and Greyhound(R) devices, all designed to minimize vessel trauma and the risk of emboli during surgical procedures.
Company Legacy
Novare Surgical Systems, Inc. was an active developer and innovator in the early 2000s, receiving notable recognition such as a 2008 Medical Design Excellence Award for its RealHand HD instruments. The company's strategic focus shifted entirely to MIS devices around 2006. In February 2011, Novare Surgical Systems sold one of its former flagship cardiac products, the ENCLOSE II Anastomosis Assist Device, to Vitalitec International, Inc.
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