Inspire II Implantable Nerve Stimulator for Obstructive Sleep Apnea

Inspire Medical Systems, a spin-out of Medtronic, has developed an implantable electronic stimulator for the treatment of obstructive sleep apnea (OSA), and now implanted it in a first patient. Because muscles in the upper airway relax more than necessary in some OSA patients, the passage gets blocked and air can't flow repeatedly during sleep. The company's Inspire II System applies an electric current to the hypoglossal nerve at proper times by sensing the pulmonary pressure of the patient. Of note, Inspire Medical has received FDA approval for the device.

More about the device from the product page:

The Inspire II system consists of an implantable pulse generator, a pulmonary pressure sensor and a stimulation lead that delivers the electrical impulses to the patient's hypoglossal nerve. The hypoglossal nerve is the twelfth cranial nerve that is located along the side of the neck and leads to the tongue. The unique closed-loop design of the Inspire II system senses a patient's respiratory effort during sleep and provides hypoglossal nerve stimulation to maintain an open airway synchronous with respiration. Patients have a programming device that is used to turn the device on at bedtime and to turn the unit off during non-sleep periods. The stimulation delivered is sufficient enough to evoke a response from the nerve but at a low enough level to not disturb the patient's sleep. A physician controller unit, used during visits to the patient's treating physician, is used to monitor the therapy and make adjustments to the device as needed for the patient's unique physiology

Press release: Inspire Medical Systems Completes First Implant of the Inspire II System to Treat Obstructive Sleep Apnea ...

Product page: Inspire II System ...

Capnostream 20, a Smart Capnography System, Gets FDA OK

Oridion Systems Ltd., a company out of Jerusalem, Israel, has received FDA 510(k) approval to market the firm's Capnostream 20 CO₂ Monitor with Integrated Pulmonary Index™.

Features from the product page and the press release:

The Integrated Pulmonary Index™, the latest Oridion Smart Capnography™ initiative, utilizes sophisticated algorithms to integrate the real time measures and interactions of four complex parameters – end tidal CO2 (EtCO2), respiration rate, pulse rate and SpO2 (oxygen saturation) into a single index value. The result is displayed on a scale from 1 10, where 10 indicates optimal pulmonary status.

By using the Integrated Pulmonary Index™, clinicians can quickly and easily assess a patient’s ventilation status and monitor a patient’s changing condition, thus facilitating more timely interventions to reduce patient risk and improve outcomes.

Dual parameter monitor
Supports the current standard of care providing CO2 and a compatible range of SpO2 technologies and sensors

Simple user interface with color screen
Routine functions are accessed with 2 clicks

72 hour trends
Review patient history

Event marking
Compare events and medication administration to changes in patient status

Nurse call
Keeps you in touch with the status of your patients

Internal printer
Convenient bedside documentation

We think that such a device might come in handy for a variety of clinical settings, such as monitoring of patients during office-based anesthetics, recovery room monitoring, anesthesia in endoscopy suits, etc.

Press release: Oridion Receives FDA 510(k) Clearance for Capnostream™ 20 Monitor with Integrated Pulmonary Index ...

Product page: The Capnostream™ 20 ...

Electrical Nerve Stimulator for Drug Resistant Pain Gets Green Light in U.S.

The FDA has given 510(k) approval to Competitive Technologies, Inc. (Fairfield, CT) to market a pain management device for cases that are not sufficiently responding to drugs and other therapies. The company says its electromedical system sends electronic scrambling messages to the central nervous system, and effectively tricks the body to believe that all is well.

From the product, described as a "transcutaneous electrical modulation pain reprocessor":

Description:

The pain management therapy technology is a non-invasive method for rapid treatment of high-intensity oncologic, neuropathic, and drug-resistant pain through a biophysical rather than a biochemical manner. The method incorporates electromedical equipment for electronic nerve stimulation, and uses the nerve fiber as a passive means to convey a message of normality to the central nervous system (CNS) by a procedure defined as scrambling or tricking of information, which then enables the CNS to modify the reflex adaptive responses — referred to as TEMPR — Transcutaneous Electrical Modulation Pain Reprocessor. It has been successfully used to treat over 2,300 patients in hospitals in Italy.

Advantages:

The non-invasive MC-5A device, using Scrambler technology, is a multiprocessor apparatus able to simultaneously treat multiple pain areas in the individual. The patient experiences longer "no pain" periods after each successive treatment.

Applications:

The global pain management market is estimated to reach $40 billion by 2010. Potential market opportunities include hospitals, nursing homes and hospices, cancer treatment centers, and pain management centers.

Product page: Pain Management Therapy...

Press release: Competitive Technologies Receives FDA Authorization for Sales of Pain Therapy Medical Device ...

All About Pediatric Reflexes

Baby Grasping Reflex



Palmar grasp reflex




Supporting reflex



Landau reflex



Rooting reflex



Foot placing reflex


Magnet reflex



Moro reflex


Babinski reflex



Plantar or foot grasp reflex



Head lifting reflex



Rooting reflex



Withdrawal reflex



Arm Recoil



Galant Reflex



Tonic neck reflex



Deep tendon reflexes



Sucking reflex



Crawling reflex

Grunting baby

Respiratory distress

bi-phasic inspiratory stridor